Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-C86 | Other Identifier | Merck Sharp & Dohme Corp |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
This trial is being done to see if an experimental drug (SEA-CD40) works when it's given with other cancer drugs to treat some types of cancer. It will also study side effects from the drug.
There are 2 parts in this trial. In one part, participants have melanoma that has come back after treatment or can't be removed by surgery. Participants in this part will get SEA-CD40 and pembrolizumab. In the other part, participants have non-small cell lung cancer (NSCLC) that has spread through their body. These participants will get SEA-CD40, pembrolizumab, carboplatin, and pemetrexed.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Melanoma Arm | Experimental | SEA-CD40 + pembrolizumab |
|
| NSCLC Arm | Experimental | SEA-CD40 + pembrolizumab + pemetrexed + carboplatin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SEA-CD40 | Drug | Given into the vein (IV; intravenously); schedule is cohort-specific |
|
| Measure | Description | Time Frame |
|---|---|---|
| Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment | cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. | From start of study treatment until CR or PR (maximum up to 15.2 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Adverse event (AE):untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Serious AE (SAE):any AE that at any dose resulted in death, life threatening, required hospitalization/prolongation of hospitalization, disabling/incapacitating, congenital anomaly/birth defects.AEs included SAEs,non-SAEs.TEAEs:newly occurring/worsening after 1st dose of treatment.Treatment related TEAEs:related to treatment;relatedness judged by investigator. TEAEs graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) v4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threating, grade 5=fatal). TESAEs:any TEAE that at any dose suspected to cause death, life-threatening, required hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Treatment related TESAEs:related to treatment; relatedness judged by investigator. |
Not provided
Inclusion Criteria:
Histologically or cytologically confirmed unresectable malignancy defined as one of the following:
Cohort 1: Relapsed and/or refractory metastatic melanoma
Uveal/ocular melanoma is excluded
Must have progressed on treatment with an anti-PD-(L)1 mAb. PD-(L)1 treatment progression is defined as meeting all of the following criteria:
Participants with a targetable BRAF mutation must have been treated with, been intolerant of, or declined treatment with BRAF/MEK targeted therapy prior to study entry
Cohort 2: Metastatic uveal melanoma
Cohort 3: Metastatic PD-(L)1-naive melanoma
Cohorts 4 and 5: Non-squamous NSCLC
Able to provide archival tumor tissue from locations not radiated prior to biopsy. If archival tumor sample is not available a fresh baseline biopsy is required.
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Measurable disease per RECIST v1.1 at baseline
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Hayman, MD | Seagen Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Highlands Oncology Group | Springdale | Arkansas | 72762 | United States | ||
| The Angeles Clinic and Research Institute |
Not provided
Not provided
Not provided
Not provided
Not provided
"Study termination by sponsor" was used as end of study reason as long-term follow-up was discontinued following decision to close enrollment. Study status is listed completed as participants were permitted to receive treatment until they met protocol defined reasons to stop. After treatment discontinuation, participants were followed through duration of safety reporting period, and then ended study as no further disease or survival follow-up was required.
This study planned to have 5 cohorts-Cohort 1: relapsed/refractory melanoma, Cohort 2: uveal melanoma, Cohort 3: programmed cell death 1 ligand 1 (PD-[L]1)-naive melanoma, Cohort 4: non-small cell lung cancer (NSCLC), programmed cell death ligand 1 (PD-L1) 1-49%, Cohort 5: NSCLC, PD-L1 < 1%. No participant was enrolled and treated in Cohort 3.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1: Relapsed/Refractory Melanoma | Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 micrograms per kilogram (mcg/kg) as an intravenous (IV) infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 milligrams (mg) as an IV infusion on Day 8 of 42-day cycles. |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2023 | Nov 28, 2024 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| pembrolizumab (KEYTRUDA®) | Drug | Given by IV; schedule is cohort-specific. |
|
| pemetrexed | Drug | Given by IV on Day 1 of each 21-day cycle. |
|
|
| carboplatin | Drug | Given by IV on Day 1 of Cycles 1-4. Each cycle will be 21 days long. |
|
|
| From first dose of the study treatment (Day 1) up to approximately 18.5 months |
| Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTCAE grade (grade 0=within normal limits, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin, creatinine increased, glomerular filtration rate (GFR) estimated decreased, glucose decreased, lactate dehydrogenase increased, potassium, sodium, total bilirubin increased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. | Baseline up to approximately 15.8 months |
| Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | In this outcome measure, number of participants with baseline laboratory hematology values as per NCI-CTCAE grade (grade 0= within normal limits, grade 1=mild, grade 2=moderate, grade 3= severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: hemoglobin- decreased and increased, leukocytes- decreased and increased, lymphocytes- decreased and increased, neutrophils decreased, platelets decreased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. | Baseline up to approximately 15.8 months |
| Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | An AE is defined as any untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Number of participants with dose interruption (SEA-CD40 treatment being temporarily stopped), dose reduction (SEA-CD40 decrease in dose) and dose discontinuation (SEA-CD40 treatment permanently stopped) due to adverse events were reported in this outcome measure. | From first dose of the study treatment (Day 1) up to approximately 18.5 months |
| Disease Control Rate (DCR) Per Investigator Assessment | DCR is defined as the percentage of participants who achieved a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator or met the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for progressive disease (PD) referring smallest sum diameter, PD: at least 20% increase (including absolute increase of at least 5 mm) in sum of diameters of target lesions, taking reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 15.2 months) |
| Duration of Response (DOR) Per Investigator Assessment | DOR: time from first documentation of OR (confirmed CR or PR) to first documentation of PD or death due to any cause, whichever occurred first. Per RECIST v1.1- CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: >=30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants with no PD and were still on study at time of analysis or were removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm. Appearance of 1 or more new lesions. Kaplan-Meier method was used. | From the first documentation of CR or PR to PD or death due to any cause or censoring, whichever occurred first (maximum up to 11.1 months) |
| Progression Free Survival (PFS) Per Investigator Assessment | PFS is defined as time from start of study treatment to first documentation of PD by RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PD and were still on study at time of analysis or who were removed from study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to start of new treatment. PD: At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is the smallest on study). In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Kaplan-Meier method was used. | From first dose of study treatment to the date of PD or death due to any cause or censoring, whichever occurred first (maximum up to 13.9 months) |
| Overall Survival (OS) | OS is defined as the time from the start of study treatment to date of death due to any cause. In the absence of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for analysis. | From start of study treatment to death due to any cause or censoring date (maximum up to 23.6 months) |
| Los Angeles |
| California |
| 90025 |
| United States |
| California Pacific Medical Center Research Institute/Sutter Medical Centre | San Francisco | California | 94115 | United States |
| University of California at San Francisco | San Francisco | California | 94134 | United States |
| Florida Cancer Specialists - South Region | Fort Myers | Florida | 33901 | United States |
| Florida Cancer Specialists - North Region | St. Petersburg | Florida | 33705 | United States |
| University Cancer & Blood Center, LLC | Athens | Georgia | 30607 | United States |
| Rush University Medical Center | Chicago | Illinois | 60612 | United States |
| Community Health Network | Indianapolis | Indiana | 46250 | United States |
| American Oncology Networks LLC | Baton Rouge | Louisiana | 70809 | United States |
| Allina Health Cancer Institute | Minneapolis | Minnesota | 55407 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Regions Cancer Care Center | Saint Paul | Minnesota | 55101 | United States |
| Morristown Medical Center/ Carol G. Simon Cancer Center | Morristown | New Jersey | 07960 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Gabrail Cancer Center Research, LLC | Canton | Ohio | 44718 | United States |
| Cleveland Clinic - Taussig Cancer Institute | Cleveland | Ohio | 44195 | United States |
| Kaiser Permanente Oregon | Portland | Oregon | 97227 | United States |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | United States |
| Tennessee Oncology-Nashville/Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| University of Texas Southwestern/Simmons Cancer Center | Dallas | Texas | 75390 | United States |
| MD Anderson Cancer Center / University of Texas | Houston | Texas | 77030-4095 | United States |
| Carbone Cancer Center / University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| CHU de Quebec-Universite Laval | Québec | G1R 2J6 | Canada |
| Hopital Foch | Suresnes | Other | 92150 | France |
| Universitatsklinikum Heidelberg | Heidelberg | Other | 69120 | Germany |
| START Madrid-CIOCC_Hospital HM Sanchinarro | Madrid | Other | 28050 | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | Other | 46010 | Spain |
| Karolinska University Hospital | Stockholm | Other | 171 76 | Sweden |
| Cohort 2: Uveal Melanoma |
Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| FG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg per meter square (/m^2) as an IV infusion on Day 1 of 21-day cycles and Carboplatin area under curve (AUC) 5 milligrams/milliliter/minute (mg/mL/min) as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| FG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety analysis set included all participants who received any amount of study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1: Relapsed/Refractory Melanoma | Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| BG001 | Cohort 2: Uveal Melanoma | Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| BG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| BG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Confirmed Objective Response Rate (cORR) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) Per Investigator Assessment | cORR is defined as the percentage of participants achieving a confirmed complete response (CR) or partial response (PR) according to RECIST v1.1. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (<10 millimeter [mm] short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. | The response evaluable (RE) analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From start of study treatment until CR or PR (maximum up to 15.2 months) |
|
|
| ||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Related TEAEs, Greater Than or Equal to (>=) Grade 3 TEAEs, Treatment Emergent Serious Adverse Event (TESAE), Treatment Related TESAE | Adverse event (AE):untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Serious AE (SAE):any AE that at any dose resulted in death, life threatening, required hospitalization/prolongation of hospitalization, disabling/incapacitating, congenital anomaly/birth defects.AEs included SAEs,non-SAEs.TEAEs:newly occurring/worsening after 1st dose of treatment.Treatment related TEAEs:related to treatment;relatedness judged by investigator. TEAEs graded according to National Cancer Institute Common Terminology Criteria for AEs (NCI-CTCAE) v4.03 (grade 1=mild, grade 2=moderate, grade 3=severe, grade 4=life-threating, grade 5=fatal). TESAEs:any TEAE that at any dose suspected to cause death, life-threatening, required hospitalization, disabling/incapacitating, congenital anomaly/birth defect. Treatment related TESAEs:related to treatment; relatedness judged by investigator. | The safety analysis set included all participants who received any amount of study drug. | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to approximately 18.5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Serum Chemistry Laboratory Abnormalities Assessed by NCI CTCAE | In this outcome measure, number of participants with baseline laboratory chemistry values as per NCI-CTCAE grade (grade 0=within normal limits, grade 1=mild, grade 2=moderate, grade 3=severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: alanine aminotransferase increased, albumin decreased, alkaline phosphatase increased, aspartate aminotransferase increased, calcium corrected for albumin, creatinine increased, glomerular filtration rate (GFR) estimated decreased, glucose decreased, lactate dehydrogenase increased, potassium, sodium, total bilirubin increased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. | The safety analysis set included all participants who received any amount of study drug. | Posted | Count of Participants | Participants | Baseline up to approximately 15.8 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Grade Shift From Baseline to Maximum Post-Baseline in Hematology Parameters Assessed by NCI CTCAE | In this outcome measure, number of participants with baseline laboratory hematology values as per NCI-CTCAE grade (grade 0= within normal limits, grade 1=mild, grade 2=moderate, grade 3= severe, grade 4= life-threatening) and corresponding changes or shift to the worst CTC grades post baseline were presented. Laboratory parameters evaluated: hemoglobin- decreased and increased, leukocytes- decreased and increased, lymphocytes- decreased and increased, neutrophils decreased, platelets decreased. Baseline was defined as last non-missing grade before first dose of study treatment and worst post-baseline value defined as worst value post study treatment. Only those categories in which at least 1 participant had data in any reporting group were reported. | The safety analysis set included all participants who received any amount of study drug. | Posted | Count of Participants | Participants | Baseline up to approximately 15.8 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment Interruptions, Dose Reductions, Treatment Discontinuations Due to Adverse Events | An AE is defined as any untoward medical occurrence in participant/clinical investigational participant administered medicinal product which doesn't necessarily have causal relationship with treatment. Number of participants with dose interruption (SEA-CD40 treatment being temporarily stopped), dose reduction (SEA-CD40 decrease in dose) and dose discontinuation (SEA-CD40 treatment permanently stopped) due to adverse events were reported in this outcome measure. | The safety analysis set included all participants who received any amount of study drug. | Posted | Count of Participants | Participants | From first dose of the study treatment (Day 1) up to approximately 18.5 months |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Disease Control Rate (DCR) Per Investigator Assessment | DCR is defined as the percentage of participants who achieved a confirmed CR or PR according to RECIST v1.1 as assessed by the investigator or met the stable disease (SD) criteria at least once after start of study treatment at a minimum interval of 5 weeks. CR: disappearance of all target, non-target lesions, all lymph nodes must be non-pathological in size (<10 mm short axis), PR: at least 30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters persistence of one or more non-target lesions. SD: neither sufficient shrinkage to qualify for PR nor sufficient increase in lesions to qualify for progressive disease (PD) referring smallest sum diameter, PD: at least 20% increase (including absolute increase of at least 5 mm) in sum of diameters of target lesions, taking reference smallest sum on study and/or unequivocal progression of existing non-target lesions and/or appearance of 1 or more new lesions. | The RE analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first dose of study treatment until the first documented CR, PR or SD or new anticancer therapies or death, whichever occurred first (maximum up to 15.2 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Per Investigator Assessment | DOR: time from first documentation of OR (confirmed CR or PR) to first documentation of PD or death due to any cause, whichever occurred first. Per RECIST v1.1- CR: disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to <10 mm. PR: >=30% decrease in sum of diameters of target lesions, taking as reference baseline sum diameters. Participants with no PD and were still on study at time of analysis or were removed from study prior to documentation of PD were censored at last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at last disease assessment prior to start of new treatment. PD: at least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study. In addition to relative increase of 20%, sum must demonstrate absolute increase of 0.5 cm. Appearance of 1 or more new lesions. Kaplan-Meier method was used. | The RE analysis set included all participants with measurable disease at baseline who received any amount of study drug and had at least one post-baseline disease assessment per RECIST v1.1 or discontinued study treatment. Here, ''Overall Number of Participants Analyzed'' signifies participants with confirmed CR or PR. | Posted | Median | 95% Confidence Interval | Months | From the first documentation of CR or PR to PD or death due to any cause or censoring, whichever occurred first (maximum up to 11.1 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) Per Investigator Assessment | PFS is defined as time from start of study treatment to first documentation of PD by RECIST v1.1 or death due to any cause, whichever occurred first. Participants with no PD and were still on study at time of analysis or who were removed from study prior to documentation of PD were censored at the date of last disease assessment documenting absence of PD. Participants who started new anticancer treatment prior to documentation of PD were censored at date of last disease assessment prior to start of new treatment. PD: At least 20% increase in sum of diameters of target lesions, taking as reference smallest sum on study (this included baseline sum if that is the smallest on study). In addition to relative increase of 20%, the sum must also demonstrate an absolute increase of at least 0.5 cm. Appearance of one or more new lesions was also considered progression. Kaplan-Meier method was used. | The full analysis set (FAS) includes all participants who received any amount of study drug. | Posted | Median | 95% Confidence Interval | Months | From first dose of study treatment to the date of PD or death due to any cause or censoring, whichever occurred first (maximum up to 13.9 months) |
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | OS is defined as the time from the start of study treatment to date of death due to any cause. In the absence of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used for analysis. | The FAS includes all participants who received any amount of study drug. | Posted | Median | 95% Confidence Interval | Months | From start of study treatment to death due to any cause or censoring date (maximum up to 23.6 months) |
|
From first dose of the study treatment (Day 1) up to approximately 18.5 months for SAEs, 16.5 months for non-SAEs and 23.6 months for death
Same event may appear as both non-SAE and SAE but what is presented are distinct events. Event may be categorised as serious in 1 participant and non-serious in other, or participant may have experienced both serious and non-serious event. The safety analysis set included all participants who received any amount of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort 1: Relapsed/Refractory Melanoma | Participants with relapsed/refractory melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. | 11 | 21 | 4 | 21 | 17 | 21 |
| EG001 | Cohort 2: Uveal Melanoma | Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. | 8 | 39 | 5 | 39 | 37 | 39 |
| EG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). | 3 | 9 | 5 | 9 | 8 | 9 |
| EG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). | 1 | 8 | 5 | 8 | 7 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypophysitis | Endocrine disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Large intestine perforation | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Concussion | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Overdose | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Suicidal ideation | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Peripheral arterial occlusive disease | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Peripheral artery stenosis | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypoacusis | Ear and labyrinth disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hyperthyroidism | Endocrine disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Lacrimation increased | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Defaecation urgency | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eructation | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Immune-mediated enterocolitis | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Chills | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v26.1 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Rash pustular | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Suspected COVID-19 | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v26.1 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Skull fractured base | Injury, poisoning and procedural complications | MedDRA v26.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v26.1 | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypocalcaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypomagnesaemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hyponatraemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Malnutrition | Metabolism and nutrition disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Tumour pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v26.1 | Systematic Assessment |
| |
| Amnesia | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Balance disorder | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Metabolic encephalopathy | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Radiculopathy | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Irritability | Psychiatric disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pollakiuria | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Vulvovaginal rash | Reproductive system and breast disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hiccups | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pain of skin | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Skin haemorrhage | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA v26.1 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 18, 2024 | Nov 28, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D000098943 | Uveal Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014604 | Uveal Neoplasms |
| D005134 | Eye Neoplasms |
| D005128 | Eye Diseases |
| D014603 | Uveal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C582435 | pembrolizumab |
| D000068437 | Pemetrexed |
| D016190 | Carboplatin |
| ID | Term |
|---|---|
| D006147 | Guanine |
| D007042 | Hypoxanthines |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005971 | Glutamates |
| D024342 | Amino Acids, Acidic |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000600 | Amino Acids, Dicarboxylic |
| D056831 | Coordination Complexes |
| D009930 | Organic Chemicals |
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 | Cohort 2: Uveal Melanoma | Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| OG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|
Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| OG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|
| OG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|
| Cohort 4: NSCLC, PD-L1 1-49% |
Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|
| OG001 | Cohort 2: Uveal Melanoma | Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| OG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|
| OG001 | Cohort 2: Uveal Melanoma | Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| OG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|
Participants with uveal melanoma, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 1 and Day 22 of 42-day cycles along with Pembrolizumab 400 mg as an IV infusion on Day 8 of 42-day cycles. |
| OG002 | Cohort 4: NSCLC, PD-L1 1-49% | Participants with NSCLC, PD-L1 1-49%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|
| OG003 | Cohort 5: NSCLC, PD-L1 < 1% | Participants with NSCLC, PD-L1 <1%, were administered SEA-CD40 10 mcg/kg as an IV infusion on Day 3 of 21-day cycles along with Pembrolizumab 200 mg as an IV infusion on Day 1 of 21-day cycles and Pemetrexed 500 mg/m^2 as an IV infusion on Day 1 of 21-day cycles and Carboplatin AUC 5 mg/mL/min as an IV infusion on Day 1 of 21-day (Cycles 1-4). |
|
|