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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001358-24 | EudraCT Number |
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Study prematurely terminated as the experimental treatments evaluated in study B9991040 may not provide additional clinical benefit over current or future Standard of Care in the different therapeutic indications that this trial was to evaluate.
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| Name | Class |
|---|---|
| EMD Serono | INDUSTRY |
| Nektar Therapeutics | INDUSTRY |
| Astellas Pharma Inc | INDUSTRY |
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Evaluation of the combination of avelumab + bempegaldesleukin (NKTR-214 ) in locally advanced squamous cell carcinoma of the head and neck ( metastatic SCCHN) and avelumab + bempegaldesleukin (NKTR-214) + talazoparib or enzalutamide in metastatic castration resistant prostate cancer (mCRPC).
Phase 1b/ Phase 2 Design
Phase 1b will be the sequential dose-finding study.
Once the Phase 1b component is completed, Phase 2 will be initiated to further evaluate the safety and anti-tumor activity across combinations of therapy.
Combination A will enroll participants with SCCHN.
Combination B and C will enroll participants with mCRPC
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination A | Experimental | Avelumab + Bempegaldesleukin (NKTR-214) for treatment of locally recurrent (not amendable for treatment with curative intent) or metastatic squamous cell carcinoma of the head and neck |
|
| Combination B | Experimental | Avelumab + Bempegaldesleukin (NKTR-214) + Talazoparib for treatment of metastatic castration-resistant prostate cancer (mCRPC). Phase 2 will focus on enrolling participants with DDR defect positive mCRPC. |
|
| Combination C | Experimental | Combination C: Avelumab + Bempegaldesleukin (NKTR-214) + Enzalutamide for Treatment of mCRPC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| avelumab | Drug | Investigational fully human anti-PD-L1 monoclonal antibody |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLT) | DLTs were graded according to NCI- CTCAE version 4.03 and coded using the latest version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) as event category and MedDRA primary system organ class (SOC) body term as Body System category. | Cycle 1 of the treatment period (28 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Response (DR) | DR was defined, for participants with a confirmed Objective Response (OR), as the time from the first documentation of OR to the date of first documentation of progressive disease (PD) or death due to any cause. The documentation of PD was defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. If a subject had not had an event (PD or death), DR was censored at the date of last adequate tumor assessment. As there were no objective responses in the study, no participant met the definition of analysis population. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States | ||
| GZA Ziekenhuizen campus Sint-Augustinus |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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4 participants screened for this study, 1 of the 4 participants was a screen failure, 3 participants were enrolled and received study treatment in Combination A.
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| ID | Title | Description |
|---|---|---|
| FG000 | Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 27, 2019 | Aug 2, 2021 |
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Combination A: Avelumab + Bempegaldesleukin (NKTR-214) for treatment of locally recurrent (not amendable for treatment with curative intent) or metastatic squamous cell carcinoma of the head and neck
Combination B: Avelumab + Bempegaldesleukin (NKTR-214) + Talazoparib for treatment of metastatic castration-resistant prostate cancer (mCRPC). Phase 2 will enroll participants with DDR defect positive mCRPC.
Combination C: Avelumab + Bempegaldesleukin (NKTR-214) + Enzalutamide for Treatment of mCRPC
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| Bempegaldesleukin | Drug | Investigational CD122-biased cytokine agonist |
|
|
| talazoparib | Drug | poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor |
|
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| enzalutamide | Drug | androgen receptor inhibitor |
|
|
| Approximately 8 months (246 days). |
| Time to Tumor Response (TTR) | TTR was defined, for participants with objective response, as the time from the date of first dose of study treatment to the first documentation of objective response (Complete Response or Partial Response) which was subsequently confirmed. As there were no objective responses in the study, no participant met the definition of analysis population. | Approximately 8 months (246 days). |
| Progression-Free Survival (PFS) | Progression-Free Survival (PFS) was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. PFS data were censored on the date of the last adequate tumor assessment for participants who did not have an event (PD or death), for participants who started new anti-cancer therapy prior to an event, or for participants with an event after two or more missing tumor assessments. Participants who did not have an adequate baseline tumor assessment or who did not have any adequate post-baseline tumor assessments were censored on the date of first dose of study treatment unless death occurred on or before the time of the second planned tumor assessment, in which case the death was considered an event. PFS time was summarized using the Kaplan-Meier method. | Approximately 8 months (246 days). |
| Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. OS time was summarized using the Kaplan-Meier method. | Approximately 8 months (246 days). |
| Pharmacokinetic (PK) Parameters - Cmax and Ctrough for Avelumab and NKTR-214 | Cmax was defined as the maximum observed plasma concentration at the end of infusion. Ctrough was defined as the predose concentration at the end of dosing interval. | Blood samples were collected on Day 1 and Day 15 in Cycle 1 and Cycle 2 for avelumab. Blood samples were collected on Day 1, Day 3, Day 4 and Day 8 in Cycle 1, Day1 and Day 8 in Cycle 2 for NKTR-214. |
| Number of Participants With Positive Anti-Drug Antibody (ADA) Results | ADA against avelumab and NKTR-214 in serum samples was determined and reported separately for ADA never-positive, ADA ever-positive participants, baseline ADA positive, treatment-boosted ADA, treatment-induced ADA, transient ADA response, persistent ADA response. For all participants, blood for ADA samples was drawn from the contralateral arm of the avelumab and NKTR-214 infusion. | Day 1 of Cycle 1, 2 and end of treatment (EOT). |
| Number of Participants With Positive Neutralizing Antibody (nAb) Results | nAb in serum samples was determined and reported separately for nAb never-positive, nAb ever-positive, baseline nAb positive, treatment-induced nAb, transient nAb response, persistent nAb response. | Day 1 of Cycle 1, 2 and EOT |
| PD-L1 Expression Level in Baseline and On-treatment Tumor Tissue | PD-L1 expression level in baseline tumor tissue, and in on-treatment tumor tissue was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and/or inflammatory cells in regions of interest. PD-L1 expression level in baseline tumor tissue and in on-treatment tumor tissue were under pathological analyses, assisted by image analysis. Participants were classified as positive or negative according to scoring algorithms and cut-offs established from internal or external sources. | On-treatment biopsy is required to be collected on Cycle 1 between Days 9 and 14 for participants in Combination A. |
| Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period | Adverse events (AEs) were any untoward medical occurrences in a participant or clinical study participants, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment). A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that, at any dose: a. Results in death, b. Was life-threatening, c. Required inpatient hospitalization or prolongation of existing hospitalization, d. Resulted in persistent disability/incapacity, e. Was a congenital anomaly/birth defect. Causality to study treatment was determined by the investigator. | Approximately 6 months (190 days) |
| Number of Participants With Laboratory Abnormalities With NCI-CTCAE Grade >= 3 - Safety Analysis Set | Liver Function Tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) were used to assess possible drug induced liver toxicity. The number of participants with at least one of the following laboratory results were summarized below: 1. (ALT ≥3 × ULN or AST ≥3 × ULN) post-baseline. 2. TBILI ≥2 × ULN post-baseline. 3. (ALP ≤2 × ULN or missing) post-baseline. | Day 1, Day 15 of each treatment cycle |
| Wilrijk |
| Antwerpen |
| 2610 |
| Belgium |
| Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy | Warsaw | Masovian Voivodeship | 02-781 | Poland |
| Hospital Quirón Barceloma | Barcelona | 08023 | Spain |
| Hospital Universitari Vall d'Hebron | Barcelona | 08035 | Spain |
| FG001 | Avelumab + NKTR-214+ Talazoparib (Combination B) | The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and talazoparib was determined at the completion of the dose finding for Combination A based on available clinical data. The lowest allowed dose for NKTR-214 was 0.003 mg/kg and the lowest allowed dose for talazoparib was 0.5 mg once daily, in which case participants with moderate renal impairment cannot be enrolled. NKTR-214 was administered prior to avelumab. Talazoparib was taken at the clinic after all procedures/assessments completed, before or after the NKTR-214 and avelumab infusions. Arm was not tested as company terminated this study on 21 May 2021. |
| FG002 | Avelumab + NKTR- 214 + Enzalutamide (Combination C) | The dose level for avelumab was fixed at 800 mg Q2W. The starting dose level for NKTR-214 and enzalutamide was determined at the completion of the dose finding for Combination A based on available clinical data. The approved label dose for enzalutamide was 160 mg once daily (QD) unless unexpected safety issues requiring it lowering according to the Bayesian Logistic Regression Model (BLRM) recommendation. NKTR-214 was administered prior to avelumab. The daily dose of enzalutamide was taken at the clinic after all procedures/assessments completed, and before or after the avelumab and NKTR-214 infusions. Arm was not tested as company terminated this study on 21 May 2021. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | 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 | Number of Participants With Dose Limiting Toxicities (DLT) | DLTs were graded according to NCI- CTCAE version 4.03 and coded using the latest version of Medical Dictionary for Regulatory Activities (MedDRA) preferred term (PT) as event category and MedDRA primary system organ class (SOC) body term as Body System category. | The DLT-evaluable analysis set included all enrolled participants in Phase 1b who receive at least one dose of the combination treatment and either experience DLT during the first cycle (28 days) of treatment, or complete the DLT observation period for the first cycle of treatment without a DLT. | Posted | Count of Participants | Participants | Cycle 1 of the treatment period (28 days) |
|
|
| ||||||||||||||||||||||||||
| Secondary | Duration of Response (DR) | DR was defined, for participants with a confirmed Objective Response (OR), as the time from the first documentation of OR to the date of first documentation of progressive disease (PD) or death due to any cause. The documentation of PD was defined using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. If a subject had not had an event (PD or death), DR was censored at the date of last adequate tumor assessment. As there were no objective responses in the study, no participant met the definition of analysis population. | All participants treated in combination A who achieved an OR. | Posted | Approximately 8 months (246 days). |
|
| |||||||||||||||||||||||||||||
| Secondary | Time to Tumor Response (TTR) | TTR was defined, for participants with objective response, as the time from the date of first dose of study treatment to the first documentation of objective response (Complete Response or Partial Response) which was subsequently confirmed. As there were no objective responses in the study, no participant met the definition of analysis population. | All participants treated in combination A who achieved an OR. | Posted | Approximately 8 months (246 days). |
|
| |||||||||||||||||||||||||||||
| Secondary | Progression-Free Survival (PFS) | Progression-Free Survival (PFS) was defined as the time from the date of first dose of study treatment to the date of the first documentation of PD or death due to any cause, whichever occurred first. PFS data were censored on the date of the last adequate tumor assessment for participants who did not have an event (PD or death), for participants who started new anti-cancer therapy prior to an event, or for participants with an event after two or more missing tumor assessments. Participants who did not have an adequate baseline tumor assessment or who did not have any adequate post-baseline tumor assessments were censored on the date of first dose of study treatment unless death occurred on or before the time of the second planned tumor assessment, in which case the death was considered an event. PFS time was summarized using the Kaplan-Meier method. | All participants treated in Combination A. | Posted | Median | 95% Confidence Interval | months | Approximately 8 months (246 days). |
| |||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) | Overall survival (OS) was defined as the time from the date of first dose of study treatment to the date of death due to any cause. Participants last known to be alive were censored at date of last contact. OS time was summarized using the Kaplan-Meier method. | All participants treated in Combination A. | Posted | Median | 95% Confidence Interval | months | Approximately 8 months (246 days). |
|
| ||||||||||||||||||||||||||
| Secondary | Pharmacokinetic (PK) Parameters - Cmax and Ctrough for Avelumab and NKTR-214 | Cmax was defined as the maximum observed plasma concentration at the end of infusion. Ctrough was defined as the predose concentration at the end of dosing interval. | The PK parameter analysis set was a subset of the safety analysis set and included participants who had at least one of the PK parameters of interest for avelumab, NKTR-214, IL-2, talazoparib, enzalutamide, or N-desmethyl-enzalutamide. | Posted | Median | 95% Confidence Interval | ug/mL | Blood samples were collected on Day 1 and Day 15 in Cycle 1 and Cycle 2 for avelumab. Blood samples were collected on Day 1, Day 3, Day 4 and Day 8 in Cycle 1, Day1 and Day 8 in Cycle 2 for NKTR-214. |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Anti-Drug Antibody (ADA) Results | ADA against avelumab and NKTR-214 in serum samples was determined and reported separately for ADA never-positive, ADA ever-positive participants, baseline ADA positive, treatment-boosted ADA, treatment-induced ADA, transient ADA response, persistent ADA response. For all participants, blood for ADA samples was drawn from the contralateral arm of the avelumab and NKTR-214 infusion. | The immunogenicity analysis set was a subset of the safety analysis set and included participants who had at least one ADA/nAb sample collected for avelumab, NKTR-214, or IL-2. | Posted | Count of Participants | Participants | Day 1 of Cycle 1, 2 and end of treatment (EOT). |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Neutralizing Antibody (nAb) Results | nAb in serum samples was determined and reported separately for nAb never-positive, nAb ever-positive, baseline nAb positive, treatment-induced nAb, transient nAb response, persistent nAb response. | The immunogenicity analysis set was a subset of the safety analysis set and included participants who had at least one ADA/nAb sample collected for avelumab, NKTR-214, or IL-2. | Posted | Count of Participants | Participants | Day 1 of Cycle 1, 2 and EOT |
|
| |||||||||||||||||||||||||||
| Secondary | PD-L1 Expression Level in Baseline and On-treatment Tumor Tissue | PD-L1 expression level in baseline tumor tissue, and in on-treatment tumor tissue was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and/or inflammatory cells in regions of interest. PD-L1 expression level in baseline tumor tissue and in on-treatment tumor tissue were under pathological analyses, assisted by image analysis. Participants were classified as positive or negative according to scoring algorithms and cut-offs established from internal or external sources. | The biomarker analysis set for biomarkers that were only measured at screening was a subset of the safety analysis set and included participants who had at least one baseline biomarker assessment. | Posted | Count of Participants | Participants | On-treatment biopsy is required to be collected on Cycle 1 between Days 9 and 14 for participants in Combination A. |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events(TEAEs), Serious TEAEs, TEAEs Leading to Death and Infusion-Related Reactions (IRRs) During On-treatment Period | Adverse events (AEs) were any untoward medical occurrences in a participant or clinical study participants, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Treatment-emergent adverse events (TEAEs) were those events with onset dates occurring during the on-treatment period. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment). A Serious Adverse Event (SAE) was defined as any untoward medical occurrence that, at any dose: a. Results in death, b. Was life-threatening, c. Required inpatient hospitalization or prolongation of existing hospitalization, d. Resulted in persistent disability/incapacity, e. Was a congenital anomaly/birth defect. Causality to study treatment was determined by the investigator. | The safety analysis set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Approximately 6 months (190 days) |
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Laboratory Abnormalities With NCI-CTCAE Grade >= 3 - Safety Analysis Set | Liver Function Tests of alanine aminotransferase (ALT), aspartate aminotransferase (AST), and total bilirubin (TBILI) were used to assess possible drug induced liver toxicity. The number of participants with at least one of the following laboratory results were summarized below: 1. (ALT ≥3 × ULN or AST ≥3 × ULN) post-baseline. 2. TBILI ≥2 × ULN post-baseline. 3. (ALP ≤2 × ULN or missing) post-baseline. | The safety analysis set included all participants who received at least one dose of study drug. | Posted | Count of Participants | Participants | Day 1, Day 15 of each treatment cycle |
|
|
Approximately 8 months (246 days) . For all causality death cases, all death cases were reported regardless if the cases happened during on-treatment period or not. In total, 2 death cases were reported. Only 1 of the 2 death cases was caused by an adverse event , the other participant died due to disease progression. Thus only 1 serious adverse event was reported. All other reported adverse events are treatment-emergent adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Avelumab + Bempegaldesleukin (NKTR-214) (Combination A) | NKTR-214 was administered prior to avelumab. NKTR-214 0.006 mg/kg was administered intravenously (IV) over 30 minutes every 2 weeks (Q2W). Avelumab 800 mg as a 1-hour IV infusion was administered after the NKTR-214 Q2W, at the investigational site on an outpatient basis on Day 1 and Day 15 of each 28-day cycle. Within the 2-day window, avelumab and NKTR-214 were administered on the same day. Dose reduction of NKTR-214 to 0.003 mg/kg Q2W was triggered if higher than expected toxicity is observed at the higher dose (risk of excessive toxicity ≥ 0.25). | 2 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA v23.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Asthenia | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| General physical health deterioration | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA v23.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Platelet count increased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v23.0 | Non-systematic Assessment |
| |
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Musculoskeletal Pain | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v23.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v23.0 | Non-systematic Assessment |
|
Phase 1b part of Combination A was conducted but not completed as company terminated this study on 21 May 2021. Termination was not due to a regulatory request or new emerging safety signals. Test for Combination B, Combination C and Phase 2 expansion for Combination A planned in the protocol were not conducted.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| 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 | Sep 3, 2019 | Aug 2, 2021 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077195 | Squamous Cell Carcinoma of Head and Neck |
| ID | Term |
|---|---|
| D002294 | Carcinoma, Squamous Cell |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| C000611752 | bempegaldesleukin |
| C586365 | talazoparib |
| C540278 | enzalutamide |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
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| Participants |
|
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| Participants |
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| Units | Counts |
|---|---|
| Participants |
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