| Primary | Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 2 of Cycle 1 | Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry. | The Target Occupancy (TO) analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of occupancy | | Day 2 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks. | | OG003 | Lead-in Phase: Avelumab 500 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 78 weeks. | | OG004 | Lead-in Phase: Avelumab 10 mg/kg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 10 mg/kg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 38.1 weeks. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00099.5± 0.01
- OG00197.7± 0.02
- OG00297.6± 0.03
- OG003
|
|
| |
| Primary | Lead-in Phase: Percent Target Occupancy (CD14+ Monocytes) at Day 1 of Cycle 2 | Target occupancy on peripheral blood CD14+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry. | The TO analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of occupancy | | Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 |
|
| Primary | Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 2 of Cycle 1 | Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry. | The TO analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose. | Posted | | Geometric Mean | Geometric Coefficient of Variation | percentage of occupancy | | Day 2 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | |
|
| Primary | Lead-in Phase: Percent Target Occupancy (CD3+ T-Cells) at Day 1 of Cycle 2 | Target occupancy on peripheral blood CD3+ T-cells by avelumab was investigated in human blood in vitro by flow cytometry. | The TO analysis set included all participants who received at least one dose of study drug and who had at least one receptor occupancy blood sample collected both pre and post Cycle 1 Day 1 dose. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | percentage of occupancy | | Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W |
|
| Primary | Expansion Phase: Percentage of Participants With Objective Response as Assessed by Blinded Independent Central Review (BICR) | Objective response: complete response (CR) or partial response (PR) according to the Response Criteria for Malignant Lymphoma, from 'start date' until disease progression (Disease progression: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease) or death due to any cause. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in sum of products of greatest diameters. PR was defined >= 50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD. | Data for this outcome measure (OM) was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | From treatment start in expansion phase until progressive disease or death due to any cause (maximum duration of 14 months) | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
|
| Primary | Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Single Dose | AUC(0-inf) was defined as area under the plasma concentration-time profile from time zero to extrapolated infinity AUC(0-inf), after single dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hour*microgram/mL (hr*mcg/mL) | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. |
|
| Primary | Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf) of Avelumab After Multiple Dose | AUC(0-inf) was defined as area under the plasma concentration-time profile from time zero to extrapolated infinity AUC(0-inf), after multiple dose. | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose, 1, 6, 24, 144, 312, 336 and 504 hours post-dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | |
|
| Primary | Lead-in Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Single Dose | | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | micrograms per milliliter (mcg/mL) | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | |
|
| Primary | Lead-in Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Multiple Dose | | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | |
|
| Primary | Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Single Dose | AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after single dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*mcg/mL | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. |
|
| Primary | Lead-in Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab After Multiple Dose | AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after multiple dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | hr*mcg/mL | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. |
|
| Primary | Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Single Dose | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after single dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | |
|
| Primary | Lead-in Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Multiple Dose | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half of avelumab, after multiple dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | days | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | |
|
| Primary | Lead-in Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Single Dose | Time to reach maximum observed plasma concentration of avelumab, after single dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | hours | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W |
|
| Primary | Lead-in Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Multiple Dose | Time to reach maximum observed plasma concentration of avelumab, after multiple dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | hours | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 |
|
| Primary | Lead-in Phase: Pre-Dose Concentration During Multiple Dosing (Ctrough) of Avelumab After Multiple Dose | | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | | pre-dose, 1, 6, 24, 144, and 312 hours post-dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | |
|
| Primary | Lead-in Phase: The Last Time Point of the Last Quantifiable Concentration (Tlast) of Avelumab After Single Dose | The last time point of the last quantifiable concentration (Tlast) of avelumab, after single dose. | The PK parameter analysis set included all participants who received at least one dose of study drug and those who had at least one of the PK parameters of interest for avelumab. | Posted | | Median | Full Range | hours | | pre-dose, 1, 6, 24, 144, 312 and 527 hours post-dose on Day 1 of Cycle 1 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | |
|
| Primary | Lead-in Phase: The Last Time Point of the Last Quantifiable Concentration (Tlast) of Avelumab After Multiple Dose | The last time point of the last quantifiable concentration (tlast) of avelumab, after multiple dose. | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose, 1, 6, 24, 144, 312, 336 and 504 hours post-dose on Day 1 of Cycle 2 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks. |
|
| Secondary | Lead-in Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related TEAEs and TEAEs Graded >=3 as Per National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03: Grade 3: severe or medically significant but not immediately life-threatening, or prolongation of existing hospitalization indicated; Grade 4: life-threatening consequence; Grade 5: death related to AE. SAE was an AE resulting in any of following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or congenital anomaly. A TEAEs: an event that emerged during treatment period (From first dose of study drug until end of open label phase [From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months)] that was absent before treatment,or worsened during treatment period relative to pre-treatment state. AE was considered related to study drug if event was assessed by investigator as probably or possibly related. | Safety analysis set included all participants who receive at least one dose of study drug. | Posted | | Count of Participants | | Participants | | From first dose of study drug to 90 days after last administration of study drug (maximum duration of 32 months) | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. |
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| Secondary | Lead-in Phase: Number of Participants With Laboratory Abnormalities Graded Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | Hematology: Anemia (Grade)G3: Hg <8.0 grams/deciliter (g/dL); lymphocyte count decreased G3: <0.5-0.2*10^9/L, G4: <0.2*10^9/L; neutrophil count decreased: G3: <1.0-0.5*10^9/L, G4: <0.5*10^9/L; platelet count decreased: G3:<50.0-25.0*10^9/L, G4: <25.0*10^9/L; white blood cell (WBC) decreased: G3: <0.2*10^9/L, G4: <1.0*10^9/L. Chemistry: [ALT, ALP increased and AST G3: >5.0-20.0*ULN, G4: >20.0*ULN]. blood bilirubin increased: G3: >3.0-10.0*ULN, G4: >10.0 *ULN. [cholesterol high: G3: >10.34 - 12.92, G4: >12.92; hypokalemia G3: <3.0-2.5, G4: <2.5]mmol/L, creatine phosphokinase (Cpk) increased: G3: >5*ULN-10*ULN, G4: >10*ULN; gamma-glutamyl transferase (Ggt) increased: G3: >5.0-20.0*ULN, G4: >20.0*ULN; [hypertriglyceridemia G3: >500-1000, G4: >1000; hypermagnesemia, G3: >3.0-8.0, G 4: >8.0]mg/dL, Lipase increased: G3: >2.0 - 5.0*ULN, G4: >5.0*ULN, Serum amylase increased: G3: >2.0 - 5.0*ULN, G4: >5.0*ULN. Only those category in which at least one participant had data were reported. | Safety analysis set included all participants who receive at least one dose of study drug. Here, 'Number analyzed' ('n') = Participants evaluable for this outcome measure for each specified category. | Posted | | Count of Participants | | Participants | | From first dose of study drug up to 90 days after the last administration of the study drug (maximum duration of 32 months) | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. |
|
| Secondary | Lead-in Phase: Number of Participants With Anti-Drug Antibodies (ADA) Status | ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. ADA never-positive participants were those who had no positive (titer less than cutpoint [22.5 percentage (%) inhibition]) ADA results at any time point. ADA ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [22.5% inhibition]) ADA result at any time point. | The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA sample collected for avelumab. | Posted | | Count of Participants | | Participants | | Day 1 up to Month 29 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. |
|
| Secondary | Expansion Phase: Number of Participants With Anti-Drug Antibodies (ADA) Status | ADA against avelumab in serum samples was determined and reported separately for ADA never-positive and ADA ever-positive participants. ADA never-positive participants were those who had no positive (titer less than cutpoint [22.5% inhibition]) ADA results at any time point. ADA ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [22.5% inhibition]) ADA result at any time point. | The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one ADA sample collected for avelumab. | Posted | | Count of Participants | | Participants | | Day 1 up to Month 14 | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Lead-in Phase: Number of Participants With Neutralizing Antibodies (nAb) Status | nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. nAb never-positive participants were those who had no positive (titer less than cutpoint [0.71]) nAb results at any time point. nAb ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [0.71]) nAb result at any time point. | The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one nAb sample collected for avelumab. | Posted | | Count of Participants | | Participants | | Day 1 up to Month 29 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. |
|
| Secondary | Expansion Phase: Number of Participants With Neutralizing Antibodies (nAb) Status | nAb against avelumab in serum samples was determined and reported separately for nAb never-positive and nAb ever-positive participants. nAb never-positive participants were those who had no positive (titer less than cutpoint [0.71]) nAb results at any time point. nAb ever-positive participants were defined as those who had at least one positive (titer greater than or equal to cutpoint [0.71]) nAb result at any time point. | The immunogenicity analysis set included all participants who received at least one dose of study drug and who had at least one nAb sample collected for avelumab. | Posted | | Count of Participants | | Participants | | Day 1 up to Month 14 | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Lead-in Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab | Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum ADA titer (180, 4860, 43740 and 131220) are reported. | Analysis was performed on participants who had received at least one dose of study drug and who had ADA ever-positive results. Here "0" in overall number of participants analyzed signifies that there were no ADA ever-positive participants in that specified group". | Posted | | Count of Participants | | Participants | | Day 1 up to Month 29 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 |
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| Secondary | Expansion Phase: Number of ADA Ever Positive Participants For Each Serum ADA Titers for Avelumab | Serum samples were assayed for ADA using a validated analytical method. Number of ADA ever positive participants for each serum ADA titer (180, 4860, 43740 and 131220) are reported. | Analysis was performed on participants who had received at least one dose of study drug and who had ADA ever-positive results. | Posted | | Count of Participants | | Participants | | Day 1 up to Month 14 | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Lead-in Phase: Number of nAb Ever Positive Participants For Serum nAb Titer for Avelumab | Serum samples were assayed for nAb using a validated analytical method. Number of nAb ever positive participants for serum nAb titer (1) is reported. | Analysis was performed on participants who had received at least one dose of study drug and who had nAb ever-positive results. Here "0" in overall number of participants analyzed signifies that there were no nAb ever-positive participants in that specified group. | Posted | | Count of Participants | | Participants | | Day 1 up to Month 29 | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W |
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| Secondary | Expansion Phase: Number of nAb Ever Positive Participants For Serum nAb Titer for Avelumab | Serum samples were assayed for nAb using a validated analytical method. | Analysis was performed on participants who had received at least one dose of study drug and who had nAb ever-positive results. Here "0" in overall number of participants analyzed signifies that there were no nAb ever-positive participants in the specified group. | Posted | | | | | | Day 1 up to Month 14 | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Lead-in Phase: Number of Participants With Phenotype of Tumor Infiltrating Lymphocytes (TILs) in Tumor Biopsy | | Data for this outcome measure was not collected and analyzed due to lack of availability of tumor biopsy tissue for analysis. | Posted | | | | | | Day 1 (pre-dose) and Day 14 of Cycle 1, Day 7 of Cycle 2, Day 1 (pre-dose) of Cycle 3, 5, 7; and at End of Treatment (EOT) (maximum duration of 29 months) | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks. |
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| Secondary | Lead-in Phase: Number of Participants With Gene Expression of Transcripts Associated With Immune Activation and Regulation | | Data for this outcome measure was not collected and analyzed due to lack of availability of tumor biopsy tissue for analysis. | Posted | | | | | | Day 1 (pre-dose) and Day 14 of Cycle 1, Day 7 of Cycle 2, Day 1 (pre-dose) of Cycle 3, 5, 7; and at End of Treatment (maximum duration of 29 months) | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks. |
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| Secondary | Lead-in Phase: Number of Participants With T Cell Immunophenotype | | Data for this outcome measure was not collected and analyzed, as the assay (which was planned for this parameter) could not be used due to quality issues. | Posted | | | | | | Day 1 of Cycles 1, 2, 3, 4, 7, 10 and at End of Treatment (maximum duration of 29 months) | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. | | OG002 | Lead-in Phase: Avelumab 500 mg Q3W | Participants with relapsed/refractory cHL received an IV infusion of 500 mg of avelumab, Q3W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 51.1 weeks. |
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| Secondary | Lead-in Phase: Percentage of Participants With Objective Response as Assessed by Investigator | Objective response: complete response (CR) or partial response (PR) according to the Response Criteria for Malignant Lymphoma, from 'start date' until disease progression (Disease progression: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease) or death due to any cause. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in sum of products of greatest diameters. PR was defined >= 50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD. | The FAS included all randomized participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From randomization until disease progression or death due to any cause (maximum duration of 32 months) | | | | ID | Title | Description |
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| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | |
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| Secondary | Lead-in Phase: Percentage of Participants With Disease Control (DC) as Assessed by Investigator | DC: best overall response of CR, PR, or stable disease (SD). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75% in sum of the products of greatest diameters. PR was defined >=50% decreased in SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in SPD and SD was defined as < PR but not progressive disease. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression. (Disease progression: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease). | FAS included all randomized participants. | Posted | | Number | 95% Confidence Interval | percentage of participants | | From randomization to PD, death or start of new anti-cancer therapy (maximum duration of 32 months) | | | | ID | Title | Description |
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| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. |
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| Secondary | Lead-in Phase: Time to Tumor Response (TTR) as Assessed by Investigator | TTR was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD. | The FAS included all randomized participants. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Median | Full Range | months | | From the date of randomization to the first documentation of objective response (CR or PR) (maximum duration of 32 months) | | | | ID | Title | Description |
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| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W |
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| Secondary | Lead-in Phase: Duration of Response (DR) as Assessed by Investigator | DR is defined, for participants with an objective response, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective PD or to death due to any cause, whichever occurs first. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD.(PD: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease). | The FAS included all randomized participants. Here, Overall Number of participants analyzed signifies participants who were evaluable for this outcome measure. | Posted | | Median | 95% Confidence Interval | months | | From first documentation of objective response to date of first documentation of objective PD or death due to any cause (maximum duration of 32 months) | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. |
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| Secondary | Lead-in Phase: Progression-Free Survival (PFS) as Assessed by Investigator | PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression as per RECIST 1.1, was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered as progression of disease. | The FAS included all randomized participants. | Posted | | Median | 95% Confidence Interval | months | | From randomization to the date of progression of disease or death due to any cause, whichever occurs first (maximum duration of 32 months) | | | | ID | Title | Description |
|---|
| OG000 | Lead-in Phase: Avelumab 70 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 70 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was approximately of 47.1 weeks. | | OG001 | Lead-in Phase: Avelumab 350 mg Q2W | Participants with relapsed/refractory cHL received an IV infusion of 350 mg of avelumab, Q2W until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination by the Sponsor, whichever occurred first. Maximum treatment exposure was of 123 weeks. |
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| Secondary | Expansion Phase: Percentage of Participants With Objective Response as Assessed by Investigator | Objective response was defined as CR or PR according to the Response Criteria for Malignant Lymphoma, from 'start date' until disease progression or death due to any cause. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the SPD of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD. (PD: >= 20% and >= 5-mm increase in sum of target lesion diameters in reference to smallest sum on study and/or substantial worsening in non-target disease). | Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | From treatment start in expansion phase until disease progression or death due to any cause (maximum duration of 14 months) | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Time to Tumor Response (TTR) as Assessed by Investigator and by Blinded Independent Central Review (BICR) | Time to Tumor Response (TTR) was defined, for participants with an objective response as the time from 'start date' to the first documentation of objective tumor response (CR or PR). CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD. | Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | From treatment start in expansion phase to first documentation of objective response (CR or PR) (maximum duration of 14 months) | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Duration of Response (DR) as Assessed by Investigator and by Blinded Independent Central Review (BICR) | Duration of Response (DR) is defined, for participants with an objective response, as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of objective progression of disease (PD) or to death due to any cause, whichever occurs first. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD. | Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | From first documentation of objective response in expansion phase to date of first documentation of objective PD or death due to any cause (maximum duration of 14 months) | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Percentage of Participants With Disease Control (DC) as Assessed by Investigator and by Blinded Independent Central Review (BICR) | Disease Control (DC) was defined as the best overall response of CR, PR, or SD. CR was defined as all lymph nodes must have regressed to normal size(less than or equal to 1.5 cm in greatest diameter if >1.5 cm before therapy). Previously involved nodes that were 1.1 to 1.5 cm in greatest diameter must have decreased to less than or equal to 1 cm or by more than 75 percent in the sum of the products of the greatest diameters. PR was defined >=50% decreased in the sum of products of the greatest diameters (SPD) of 6 largest dominant nodes or nodal masses. No increase in size of nodes, liver or spleen and no new sites of disease. Splenic and hepatic nodules must regress by >=50% in the SPD and Stable Disease was defined as less than a PR but not progressive disease. To qualify as a best overall response of SD, at least one SD assessment must be observed >=6 weeks after start date and before disease progression. | Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | From treatment start in expansion phase to PD, death or start of new anti-cancer therapy (maximum duration of 14 months) | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Progression-Free Survival (PFS) as Assessed by Investigator and by Blinded Independent Central Review (BICR) | PFS was defined as time (in months) from date of randomization to the first documentation of disease progression or death (due to any cause), whichever occurred first. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must have also demonstrated an absolute increase of at least 5 mm. The appearance of one or more new lesions was also considered progression. Analysis was performed using a Cox's Proportional Hazard model stratified by the randomization strata and a stratified log-rank test. | Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | From treatment start in expansion phase to date of first documentation of objective Progressive Disease (PD) or death due to any cause, whichever occurs first (maximum duration of 14 months) | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Overall Survival | Overall survival was defined as the time (in months) from the date of randomization to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. Analysis was performed using Kaplan-Meier method. | Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | From treatment start in expansion phase until death (maximum duration of 14 months) | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), Related TEAEs and TEAEs Graded >=3 Based on, National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. As per NCI-CTCAE version 4.03: Grade 3: severe or medically significant but not immediately life-threatening, or prolongation of existing hospitalization indicated; Grade 4: life-threatening consequence; Grade 5: death related to AE. SAE was an AE resulting in any of following outcomes: death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or congenital anomaly. TEAEs: an event that emerged during treatment period (From first dose of study drug until end of expansion phase [From first dose of study drug to 90 days after last administration of study drug (maximum duration of 14 months)] that was absent before treatment, or worsened during treatment period relative to pre-treatment state. AE was considered related to study drug if event was assessed by investigator as probably or possibly related. | Safety analysis set included all participants who receive at least one dose of study drug. | Posted | | Count of Participants | | Participants | | From first dose of study drug to 90 days after last administration of study drug (maximum duration of 14 months) | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Number of Participants With Laboratory Abnormalities of Grade 3 Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 | As per NCI-CTCAE v 4.03, Grade >= 3 criteria were; Alanine aminotransferase: 0 LLN, 0.58 ULN microkat/L (microkatal /L); GGT: 0 LLN, 0.63 ULN microkat/L, Glucose: 4.11 LLN, 5.88 ULN mmol/L, LOW Sodium: 136 LLN, 146 ULN mmol/L; Prothrombin intl. normalized ratio: 0.9 LLN, 1.2 ULN; LOW lymphocytes (10^9/L); 1.5 LLN, 4.0 ULN; Platelets (10^9/L): 130 LLN, 400 ULN. Only those category in which at least one participant had data were reported. | Safety analysis set included all participants who receive at least one dose of study drug. | Posted | | Count of Participants | | Participants | | From first dose of study drug to 90 days after last administration of study drug (maximum duration of 14 months) | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Number of Participants With Acute and Chronic Graft Versus Host Disease (GVHD) | Acute GvHD is a reaction of donor immune cells against host tissues. The three main tissues that acute GvHD affects are the skin, liver and gastrointestinal tract. Chronic GvHD is a syndrome of variable clinical features resembling autoimmune and other immunologic disorders. Manifestations of chronic GvHD may be restricted to a single organ or site or may be widespread, with profound impact on quality of life. | FAS included all randomized participants. | Posted | | Count of Participants | | Participants | | From treatment start in expansion phase up to 90 days after last administration of study drug (maximum duration of 14 months) | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Area Under the Plasma Concentration-Time Profile From Time Zero to Extrapolated Infinity (AUC0-inf), After Single and Multiple Dose | AUC(0-inf) was defined as area under the plasma concentration-time profile from time zero to infinity AUC(0-inf), after single and multiple dose. | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3 | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Maximum Observed Plasma Concentration (Cmax) of Avelumab After Single and Multiple Dose | | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3 | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Area Under the Plasma Concentration-Time Profile From Time Zero (Pre-Dose) to the Next Dose (AUC0-tau) of Avelumab, After Single and Multiple Dose | AUCtau was defined as area under the plasma concentration-time profile from time zero (pre-dose) to the next dose (AUC0-tau) of avelumab, after single and multiple dose. | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3 | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Terminal Elimination Half-Life (t1/2) of Avelumab After Single and Multiple Dose | Terminal elimination half-life is the time measured for the plasma concentration to decrease by one half. | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3 | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Time to Attain Maximum Observed Plasma Concentration (Tmax) of Avelumab After Single and Multiple Dose | | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3 | | | | ID | Title | Description |
|---|
| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Pre-Dose Concentration During Multiple Dosing (Ctrough) of Avelumab After Single and Multiple Dose | | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3 | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: The Last Time Point of the Last Quantifiable Concentration (Tlast) of Avelumab After Single and Multiple Dose | The last time point of the last quantifiable concentration (tlast), after single and multiple dose. | Data for this outcome measure was not collected due to early termination of study. | Posted | | | | | | pre-dose and 1 hour post-dose on Day 1 of Cycles 1, 2 and 3 | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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| Secondary | Expansion Phase: Number of Participants With Phenotype of Tumor Infiltrating Lymphocytes (TILs) in Tumor Biopsy | | Data for this outcome measure was not collected due to the limited number of participants were enrolled into the expansion phase prior to study termination. | Posted | | | | | | Pre-treatment tumor biopsy for baseline and on-treatment biopsy at Day 7 of Cycle 3 | | | | ID | Title | Description |
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| OG000 | Expansion Phase: Avelumab 70 mg, 500 mg Q2W | All participants received an initial dose of 70 mg Q2W avelumab for 3 cycles, Each cycle was of 14 days (2 weeks), and were monitored for safety and efficacy. Participants who achieved a CR at the 6-week tumor assessment were continued at the same dose regimen. Participants who achieved a PR at 6 weeks were continued at 70 mg Q2W for an additional 3 cycles, and if the 12-week tumor assessment still showed a PR, participants were dose escalated to 500 mg Q2W. Participants who achieved a SD at the 6-week tumor assessment, dose escalated to 500 mg Q2W. Treatment was continued until disease progression, participant refusal, unacceptable toxicity, lost to follow-up, or until study termination the Sponsor, whichever occurred first. Maximum treatment exposure was of 48 weeks. |
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