Trial · NCT03565991
Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
NCT03565991, Phase 2, Terminated, Pfizer; results first posted 2023-08-07
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors. Trials, record NCT03565991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03565991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors
- NCT number
- NCT03565991
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 202 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Locally Advanced or Metastatic Solid Tumors, Genes, BRCA 1
- Interventions
- Avelumab, Talazoparib
- First posted
- 2018-06-21
- Last updated
- 2023-09-25
- Other registries' IDs
- eudract:2018-000345-39
- Results first posted
- 2023-08-07
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months | For participants with solid tumors, except metastatic Castration Resistant Prostate Cancer (mCRPC), OR was defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1), both confirmed by repeat assessments performed no less than 4 weeks after the criteria for response were first met. For participants with mCRPC, OR was defined as the percentage of participants with a best overall soft tissue response of CR or PR per RECIST v1.1 with no evidence of confirmed bone disease progression per Prostate Cancer Working Group 3 (PCWG3) criteria. Per RECIST v1.1, CR was defined as complete disappearance of all target and non-target lesions with the exception of nodal disease. PR was defined as greater than or equal to 30% decrease under baseline of the sum of diameters of all target measurable lesions. Non-target PR lesions must be non-Progressive Disease (PD), where PD was unequivocal progression of pre-existing lesions. |
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately | An adverse event (AE) was any untoward medical occurrence in a clinical investigation where participants administered a product or medical device. TEAEs were those events with onset dates occurring during the on-treatment period. A Serious Adverse Event (SAE) was any untoward medical occurrence at any dose that: resulted in death, was life threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, or resulted in congenital anomaly/birth defect. A treatment-related AE was any untoward medical occurrence attributed to the study drug in a participant who received study drug. TEAEs were graded by the investigator using National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) v4.03 as Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. |
| Secondary | Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately | The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day). |
| Secondary | Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately | The laboratory results were graded according to the CTCAE v4.03 severity grade whenever applicable. Laboratory test abnormalities were summarized according to worst toxicity grade observed for each laboratory test. As per NCI CTCAE toxicity grading v4.03, Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = death related to AE. On-treatment period was defined as the time from the first dose of study treatment through minimum (30 days + last dose of study treatment, start day of new anti-cancer drug therapy - 1 day). |
| Secondary | Serum Lowest (Trough) Concentration (Ctrough) of Avelumab | Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 0.2 mcg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented. |
| Secondary | Serum Maximum Concentration (Cmax) for Avelumab | One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data. |
| Secondary | Plasma Ctrough for Talazoparib | Predose on Cycle 1 Days 1, 15 and Cycle 3 Day 1 | Ctrough was defined as predose concentration during multiple dosing. The determination method of Ctrough was observing directly from data. The lower limit of quantification (LLQ) was 25 pg/mL. For Cycle 1 Day 1, as the number of observations above lower limit of quantification (NALQ) = 0, summary statistics were not presented. Evaluable participants were participants with non-missing Ctrough concentrations at each specific time point and meeting 2 conditions: participants received 14 consecutive days of talazoparib dose without dosing interruption prior to sample collection (except on Cycle 1 Day 1) and sample collection within 24 hours ± 10% (2 hours and 24 minutes) after the previous day's dose and no more than 5 minutes (0.083 hours) after the administration of the dose on the day of PK sample collection. Predose PK samples on Cycle 1 Day 1 must have been collected prior to dose. |
| Secondary | Plasma Post-dose Concentrations for Talazoparib | Postdose (samples collected within 2 hours post dose plus/minus 12 minutes) on Days 1,15 of Cycle 1, and Day 1 of Cycle 3 | In this OM, the post-dose concentrations for talazoparib in plasma were reported. |
| Secondary | Number of Participants by Avelumab Anti-drug Antibody (ADA) Categories | Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | Blood samples were assayed for ADA using a validated assay. ADA never-positive = no positive ADA results at any time point. ADA ever-positive =at least one positive ADA result at any time point. Baseline ADA positive =a positive ADA result at baseline. Treatment-boosted ADA =a positive ADA result at baseline and the titer \>=8×baseline titer at least once after treatment with avelumab. Treatment-induced ADA = participant was ADA-negative at baseline and had at least one positive post-baseline ADA result; or the participant had at least one positive post-baseline ADA result if no baseline sample. Transient ADA response = participants with treatment-induced ADA had (a single positive ADA result or duration between first and last positive result \<16 weeks) and ADA result at the last assessment was not positive. Persistent ADA response =participants with treatment-induced ADA had duration between first and last positive ADA result \>=16 weeks or a positive ADA result at the last assessment. |
| Secondary | Number of Participants With Neutralizing Antibodies (Nab) Levels Against Avelumab Ever-Positive | Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | Nab ever-positive was defined as at least one positive Nab result at any time point. Samples positive for ADA with persistent treatment-induced ADA response could be analyzed for Nab. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever came first, assessed up to approximately 24 months | The analysis set included all enrolled participants who received at least 1 dose of study treatment. Participants were classified according to the cohort assigned at enrollment. | Percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately | The safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately | The safety analysis set included all enrolled participants who received at least 1 dose of study treatment. The number analyzed for each parameter in each treatment group was the number of participants evaluable for each parameter. Number of participants analyzed = participants evaluable for this outcome measure (OM), number analyzed = participants evaluable for the specific lab parameter per CTCAE criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately | The safety analysis set included all enrolled participants who received at least 1 dose of study treatment. The number analyzed for each parameter in each treatment group was the number of participants evaluable for each parameter. Number of participants analyzed = participants evaluable for this outcome measure (OM), number analyzed = participants evaluable for the specific lab parameter per CTCAE criteria. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Serum Lowest (Trough) Concentration (Ctrough) of Avelumab | Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | The avelumab PK concentration analysis set included all participants (Cohort 1 and Cohort 2 combined) who received at least 1 dose of study intervention and had at least one concentration measurement for avelumab. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = participants evaluable at the specific time point. | microgram(mcg)/milliliter(mL) | GEOMETRIC_MEAN |
| SECONDARY | Serum Maximum Concentration (Cmax) for Avelumab | One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | The avelumab PK concentration analysis set included all participants (Cohort 1 and Cohort 2 combined) who received at least 1 dose of study intervention and had at least one concentration measurement for avelumab. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = participants evaluable at the specific time point. | mcg/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma Ctrough for Talazoparib | Predose on Cycle 1 Days 1, 15 and Cycle 3 Day 1 | The talazoparib PK concentration analysis set included all participants (Cohort 1 and Cohort 2 combined) who received at least 1 dose of study intervention and had at least one Ctrough concentration measurement for talazoparib. Number of participants analyzed = number of participants evaluable for this OM. Number analyzed = participants evaluable at the specific time point. | picogram(pg)/mL | GEOMETRIC_MEAN |
| SECONDARY | Plasma Post-dose Concentrations for Talazoparib | Postdose (samples collected within 2 hours post dose plus/minus 12 minutes) on Days 1,15 of Cycle 1, and Day 1 of Cycle 3 | The Analysis Population included all participants (Cohort 1 and Cohort 2 combined) who received at least 1 dose of talazoparib, had at least one non-missing concentration measurement at any collection scheduled time point, received 14 consecutive days of talazoparib dose without dosing interruption prior to sample collection (except on Cycle 1 Day 1) and sample collection was performed within ± 10% (12 minutes) of nominal time post-dose. | pg/mL | GEOMETRIC_MEAN |
| SECONDARY | Number of Participants by Avelumab Anti-drug Antibody (ADA) Categories | Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | Number of Participants Analyzed = participants in the immunogenicity analysis set who had at least 1 ADA sample collected for avelumab. Number Analyzed (N0) = participants with at least one valid ADA result at any time point; (N1) = participants with valid baseline ADA result; (N2) = participants with valid baseline ADA results and at least one valid post-baseline ADA result; (N3) = participants with at least one valid post-baseline ADA result and without positive baseline ADA result. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Neutralizing Antibodies (Nab) Levels Against Avelumab Ever-Positive | Predose (within 2 hours before start of avelumab infusion) on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 | The immunogenicity analysis set included participants who had at least 1 Nab sample collected for avelumab. Nabs data were not collected due to insufficient number of participants with persistent treatment-induced ADA response. Therefore, the number of participants analyzed for this OM was 0. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group368
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | Cohort 1 (BRCA 1/2 Defect) | 27.7 | 95% Confidence Interval 20.9 to 35.3 | Percentage of participants | |
| Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | Cohort 2 (ATM Defect) | 7.3 | 95% Confidence Interval 1.5 to 19.9 | Percentage of participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (BRCA 1/2 Defect) | TEAEs | 156 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (ATM Defect) | TEAEs | 40 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (BRCA 1/2 Defect) | treatment-related TEAEs | 148 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (ATM Defect) | treatment-related TEAEs | 34 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (BRCA 1/2 Defect) | grade >=3 TEAEs | 114 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (ATM Defect) | grade >=3 TEAEs | 22 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 1 (BRCA 1/2 Defect) | grade >=3 treatment-related TEAEs | 85 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | Cohort 2 (ATM Defect) | grade >=3 treatment-related TEAEs | 17 | Participants |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (BReast CAncer Gene [BRCA] 1/2 Defect) | 159 | |
| Overall Study | STARTED | Cohort 2 (Ataxia Telangiectasia Mutated [ATM] Defect) | 41 | |
| Overall Study | COMPLETED | Cohort 1 (BReast CAncer Gene [BRCA] 1/2 Defect) | 1 | |
| Overall Study | COMPLETED | Cohort 2 (Ataxia Telangiectasia Mutated [ATM] Defect) | 0 | |
| Overall Study | NOT COMPLETED | Cohort 1 (BReast CAncer Gene [BRCA] 1/2 Defect) | 158 | |
| Overall Study | NOT COMPLETED | Cohort 2 (Ataxia Telangiectasia Mutated [ATM] Defect) | 41 |
Source ClinicalTrials.gov
Adverse events250
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Cohort 1 (BRCA 1/2 Defect) | 81 | 159 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2 (ATM Defect) | 18 | 41 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 1 (BRCA 1/2 Defect) | 20 | 159 | |
| other | Neutropenia | Blood and lymphatic system disorders | Cohort 2 (ATM Defect) | 4 | 41 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 1 (BRCA 1/2 Defect) | 27 | 159 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Cohort 2 (ATM Defect) | 5 | 41 | |
| other | Hypothyroidism | Endocrine disorders | Cohort 1 (BRCA 1/2 Defect) | 10 | 159 | |
| other | Hypothyroidism | Endocrine disorders | Cohort 2 (ATM Defect) | 5 | 41 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 1 (BRCA 1/2 Defect) | 5 | 159 | |
| other | Abdominal distension | Gastrointestinal disorders | Cohort 2 (ATM Defect) | 6 | 41 |
1 to 10 of 250Source ClinicalTrials.gov
See all 250 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (BRCA 1/2 Defect) | 15 | 159 |
| Total, all-cause mortality | Cohort 2 (ATM Defect) | 3 | 41 |
| Total, other adverse events | Cohort 1 (BRCA 1/2 Defect) | 153 | 159 |
| Total, other adverse events | Cohort 2 (ATM Defect) | 40 | 41 |
| Total, serious adverse events | Cohort 1 (BRCA 1/2 Defect) | 50 | 159 |
| Total, serious adverse events | Cohort 2 (ATM Defect) | 7 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36394867 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Expression in Baseline Tumor Tissue | Trial comparisons |
| Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): Number of Participants With Cancer Antigen 125 (CA-125) Response | Trial comparisons |
| Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): Number of Participants With Confirmed PSA Response | Trial comparisons |
| Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): Number of Participants With Circulating Tumor Cell (CTC) Count Conversion | Trial comparisons |
| Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): deaths from any cause | Trial comparisons |
| Cohort 1 (BRCA 1/2 Defect) vs Cohort 2 (ATM Defect): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03565991
GET https://conductscience.org/api/trials/v1/NCT03565991/registered?page=2