Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2018-000345-39 | EudraCT Number |
Not provided
Not provided
Not provided
The study was terminated since there was no need for further safety or efficacy data to be collected. The participants having benefit from the investigational treatments have been moved to a continuation study (NCT05059522)
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Avelumab in combination with talazoparib will be investigated in patients with locally advanced or metastatic solid tumors with a BRCA or ATM defect.
Avelumab is a human immunoglobulin (Ig)G1 monoclonal antibody (mAb) directed against programmed death ligand 1 (PD-L1). Avelumab selectively binds to PD-L1 and competitively blocks its interaction with programmed death receptor 1 (PD-1), thereby interfering with this key immune checkpoint inhibition pathway. Avelumab is currently being investigated as single agent and in combination with other anti cancer therapies in patients with locally advanced or metastatic solid tumors and various hematological malignancies.
Talazoparib is a potent, orally bioavailable poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor, which is cytotoxic to human cancer cell lines harboring gene mutations that compromise deoxyribonucleic acid (DNA) repair, an effect referred to as synthetic lethality, and by trapping PARP protein on DNA thereby preventing DNA repair, replication, and transcription.
Avelumab in combination with talazoparib will be investigated in patients with locally advanced (primary or recurrent) or metastatic solid tumors with a BReast CAncer susceptibility gene (BRCA)1, or BRCA2, or ataxia telangiectasia mutated (ATM) gene defect.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combination of avelumab and talazoparib | Experimental | Single arm open label |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Avelumab | Drug | IV treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford Cancer Center | Palo Alto | California | 94304 | United States | ||
| Stanford Women's Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36394867 | Derived | Schram AM, Colombo N, Arrowsmith E, Narayan V, Yonemori K, Scambia G, Zelnak A, Bauer TM, Jin N, Ulahannan SV, Colleoni M, Aftimos P, Donoghue MTA, Rosen E, Rudneva VA, Telli ML, Domchek SM, Galsky MD, Hoyle M, Chappey C, Stewart R, Blake-Haskins JA, Yap TA. Avelumab Plus Talazoparib in Patients With BRCA1/2- or ATM-Altered Advanced Solid Tumors: Results From JAVELIN BRCA/ATM, an Open-Label, Multicenter, Phase 2b, Tumor-Agnostic Trial. JAMA Oncol. 2023 Jan 1;9(1):29-39. doi: 10.1001/jamaoncol.2022.5218. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
Not provided
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.
Not provided
Not provided
Not provided
A total of 270 participants were screened for this study, 202 participants were enrolled and assigned to study treatment but 2 participants never started the treatment. In total 200 participants were treated (159 in Cohort 1 and 41 in Cohort 2).
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Cohort 1 (BReast CAncer Gene [BRCA] 1/2 Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes were enrolled in Cohort 1. Talazoparib was self-administered orally at a starting dose of 1 mg Once Daily (QD) for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour Intravenous (IV) infusion Every 2 Weeks (Q2W) on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
| 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 | Nov 15, 2018 | Mar 22, 2023 |
Not provided
Not provided
Single arm study with two cohorts enrolled in parallel.
Not provided
Not provided
Open label
Not provided
| Talazoparib | Drug | Oral treatment |
|
|
| From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately |
| Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period | 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). | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately |
| Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period | 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). | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately |
| Serum Lowest (Trough) Concentration (Ctrough) of Avelumab | 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. | Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 |
| Serum Maximum Concentration (Cmax) for Avelumab | Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data. | One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 |
| Plasma Ctrough for Talazoparib | 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. | Predose on Cycle 1 Days 1, 15 and Cycle 3 Day 1 |
| Plasma Post-dose Concentrations for Talazoparib | In this OM, the post-dose concentrations for talazoparib in plasma were reported. | 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 |
| Number of Participants by Avelumab Anti-drug Antibody (ADA) Categories | 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. | 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 With Neutralizing Antibodies (Nab) Levels Against Avelumab Ever-Positive | 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. | 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 |
| Percentage of Participants With Confirmed OR as Assessed by The Investigator | For participants with solid tumors, except mCRPC, OR was defined as a CR or PR per 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 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-PD, where PD was unequivocal progression of pre-existing lesions. | From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 24 months |
| Time to Tumor Response (TTR) as Assessed by BICR | For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a Best Overall Response (BOR) of CR or PR per RECIST v1.1. | Baseline up to approximately 24 months |
| TTR as Assessed by Investigator | For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a BOR of CR or PR per RECIST v1.1. | Baseline up to approximately 24 months |
| Duration of Response (DoR) as Assessed by BICR | For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occured first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3. | Baseline up to approximately 24 months |
| DoR as Assessed by Investigator | For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occurred first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3. | Baseline up to approximately 24 months |
| Progression Free Survival (PFS) as Assessed by BICR | For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first. | Baseline up to approximately 24 months |
| PFS as Assessed by Investigator | For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first. | Baseline up to approximately 24 months |
| Overall Survival (OS) for All Participants | OS was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact. | Baseline up to approximately 24 months |
| Time to Prostate-Specific Antigen (PSA) Progression for Participants With mCRPC | For participants with mCRPC, time to PSA progression was defined as the time from the first dose to the date that a >=25% increase in PSA with an absolute increase of >=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained >=3 weeks (21 days) later. | Baseline up to approximately 24 months |
| Number of Participants With Confirmed PSA Response | For participants with mCRPC, PSA response was defined as confirmed PSA decline >=50% compared to baseline. PSA response was calculated as a decline from baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50%. A PSA response must have been confirmed by a second consecutive value at least 3 weeks later. | Baseline up to approximately 24 months |
| Number of Participants With Circulating Tumor Cell (CTC) Count Conversion | For participants with mCRPC, CTC count conversion was defined as a decrease in CTC count from >=5 CTC per 7.5 mL of blood at baseline to <5 CTC per 7.5 mL of blood anytime on study. | Day 1 of Cycle 1 to Cycle 4 |
| Number of Participants With Cancer Antigen 125 (CA-125) Response | For participants with ovarian cancer, CA-125 response was defined as at least a 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days. | Baseline, Day 1 of each treatment Cycle, maximum up to 4.3 years approximately |
| Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Expression in Baseline Tumor Tissue | PD-L1 expression on tumor and infiltrating immune cells was measured by immunohistochemistry (IHC). PD-L1 expression level was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest. This OM reported the number of participants classified as positive according to scoring algorithms and cut-offs established from external sources. | Baseline |
| Number of Participants With Different Status for Defects in BRCA1, BRCA2 and ATM | Participants were enrolled in the two cohorts based on BRCA 1/2 and ATM defect status assessed by the local laboratory. The participant BRCA and ATM status was assessed retrospectively by central laboratory, that may differ from the status assessed by the local laboratory. The ATM participants with a negative ATM status per the central laboratory were reported to have a positive ATM status per the local laboratory. Therefore, participants with negative ATM status might have been included in the ATM defect cohort. For defects in BRCA1, BRCA2 and ATM by central laboratory analysis, participants were classified as positive, negative, not analyzable or missing. The number of participants in each category of BRCA 1 defect, BRCA 2 defect, BRCA 1 or BRCA 2 defect and ATM defect were presented. | Baseline |
| Number of Participants by Status of Tumor Mutational Burden (TMB) at Baseline | TMB was defined as the total number of mutations in the tumor genome, or number of mutations per megabase of DNA if derived from targeted sequencing. TMB categories were defined as high, low for a number of mutations per megabase >=10 and <10, respectively. The TMB category 'Not analyzable' included participants with available samples but not evaluable. The TMB category 'Missing' included participants with no sample available. The number of participants in each category at only baseline were tabulated. | Baseline |
| Palo Alto |
| California |
| 94304 |
| United States |
| Stanford Healthcare | Stanford | California | 94305 | United States |
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
| Atlanta Cancer Care -Alpharetta | Alpharetta | Georgia | 30005 | United States |
| Northside Hospital, Inc. - GCS/Athens | Athens | Georgia | 30606 | United States |
| Northside Hospital, Inc. - GCS/Annex | Atlanta | Georgia | 30341 | United States |
| Atlanta Cancer Care - Atlanta | Atlanta | Georgia | 30342 | United States |
| Northside Hospital, Inc. - Central Research Department | Atlanta | Georgia | 30342 | United States |
| Northside Hospital, Inc. - GCS/Northside | Atlanta | Georgia | 30342 | United States |
| Northside Hospital, Inc. - GCS/Canton | Canton | Georgia | 30114 | United States |
| Atlanta Cancer Care - Cumming | Cumming | Georgia | 30041 | United States |
| Atlanta Cancer Care - Decatur | Decatur | Georgia | 30033 | United States |
| Northside Hospital, Inc.-GCS/Stemmer | Decatur | Georgia | 30033 | United States |
| Atlanta Cancer Care - Stockbridge | Jonesboro | Georgia | 30236 | United States |
| Northside Hospital, Inc.-GCS/Macon | Macon | Georgia | 31217 | United States |
| Northside Hospital, Inc.-GCS/Kennestone | Marietta | Georgia | 30060 | United States |
| Ochsner Clinic Foundation | New Orleans | Louisiana | 70121 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Dana Farber Cancer institute | Boston | Massachusetts | 02215 | United States |
| Siteman Cancer Center - St.Peters | City of Saint Peters | Missouri | 63376 | United States |
| Siteman Cancer Center - West County | Creve Coeur | Missouri | 63141 | United States |
| Barnes-Jewish Hospital | St Louis | Missouri | 63110 | United States |
| Washington University Infusion Center Pharmacy | St Louis | Missouri | 63110 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| Siteman Cancer Center - South County | St Louis | Missouri | 63129 | United States |
| Siteman Cancer Center - North County | St Louis | Missouri | 63136 | United States |
| Memorial Sloan Kettering Cancer Center- Monmouth | Middletown | New Jersey | 07748 | United States |
| Memorial Sloan Kettering Cancer Center- Westchester | Harrison | New York | 10604 | United States |
| Memorial Sloan Kettering Cancer Center - Investigational Drug Service Pharmacy | Long Island City | New York | 11101 | United States |
| Laura and Isaac Perlmutter Cancer Center at NYU Langone | New York | New York | 10016 | United States |
| Laura and Isaac Perlmutter Cancer Center | New York | New York | 10016 | United States |
| NY Investigational Pharmacy | New York | New York | 10016 | United States |
| NYU Langone Medical Center | New York | New York | 10016 | United States |
| NYU Langone Radiology - 32nd Street | New York | New York | 10016 | United States |
| NYU Langone Radiology Ambulatory Care Center East 41st Street | New York | New York | 10017 | United States |
| Memorial Sloan Kettering Cancer Center - David H. Koch Center for Cancer Care (74th Street). | New York | New York | 10021 | United States |
| Rockefeller Outpatient Center | New York | New York | 10022 | United States |
| Rockefeller Outpatient Pavilion (53rd Street) | New York | New York | 10022 | United States |
| Evelyn H. Lauder Breast and Imaging Center | New York | New York | 10065 | United States |
| Memorial Hospital | New York | New York | 10065 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| White Plains Hospital | White Plains | New York | 10601 | United States |
| The Ohio State University Wexner Medical Center | Columbus | Ohio | 43210 | United States |
| The Ohio State University | Columbus | Ohio | 43210 | United States |
| Stephanie Spielman Comprehensive Breast Cancer | Columbus | Ohio | 43212 | United States |
| Martha Morehouse Medical Plaza | Columbus | Ohio | 43221 | United States |
| OSU Gynecologic Oncology at Mill Run | Hilliard | Ohio | 43026 | United States |
| Stephenson Cancer Center | Oklahoma City | Oklahoma | 73104 | United States |
| Hospital of the University of Pennsylvania/Penn Investigational Drug Services | Philadelphia | Pennsylvania | 19104 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Penn IDS Central | Philadelphia | Pennsylvania | 19104 | United States |
| Magee-Women's Hospital Women's Cancer Center | Pittsburgh | Pennsylvania | 15213 | United States |
| UPMC Hillman Cancer Center Investigational Drug Service | Pittsburgh | Pennsylvania | 15232 | United States |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | United States |
| Tennessee Oncology, PLLC | Chattanooga | Tennessee | 37404 | United States |
| The Sarah Cannon Research Institute | Chattanooga | Tennessee | 37404 | United States |
| Tennessee Oncology, PLLC | Cleveland | Tennessee | 37311 | United States |
| Tennessee Oncology, PLLC | Dickson | Tennessee | 37055 | United States |
| Tennessee Oncology, PLLC | Franklin | Tennessee | 37067 | United States |
| Tennessee Oncology, PLLC | Gallatin | Tennessee | 37066 | United States |
| Tennessee Oncology, PLLC | Hermitage | Tennessee | 37076 | United States |
| Tennessee Oncology, PLLC | Lebanon | Tennessee | 37090 | United States |
| Tennessee Oncology, PLLC | Murfreesboro | Tennessee | 37129 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37203 | United States |
| The Sarah Cannon Research Institute | Nashville | Tennessee | 37203 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37205 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37207 | United States |
| Tennessee Oncology, PLLC | Nashville | Tennessee | 37211 | United States |
| Tennessee Oncology, PLLC | Shelbyville | Tennessee | 37160 | United States |
| Tennessee Oncology, PLLC | Smyrna | Tennessee | 37167 | United States |
| The University of Texas | Houston | Texas | 77030 | United States |
| Institut Jules Bordet | Brussels | 1000 | Belgium |
| UZ Brussel | Brussels | 1090 | Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | 2650 | Belgium |
| Rigshospitalet | Copenhagen | 2100 | Denmark |
| Odense University Hospital | Odense C | 5000 | Denmark |
| Centre Jean Perrin | Clermont-Ferrand | 63000 | France |
| Groupe Hospitalier La Rochelle-Ré-Aunis | La Rochelle | 17000 | France |
| Institut Regional du Cancer de Montpellier - ICM Val d'Aurelle | Montpellier | 34298 | France |
| Presidio AO-U, Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi | Torette Di Ancona | AN | 60123 | Italy |
| IRCCS-Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) | Meldola | FC | 47014 | Italy |
| Azienda Socio-Sanitaria Territoriale Monza, Ospedale San Gerardo | Monza | MB | 20900 | Italy |
| Fondazione IRCCS, Istituto Nazionale dei Tumori | Milan | MI | 20133 | Italy |
| Istituto Europeo di Oncologia, Istituto di Ricovero e Cura a Carattere Scientifico | Milan | MI | 20141 | Italy |
| Fondazione Pascale, IRCCS, Istituto Nazionale dei Tumori | Naples | 80131 | Italy |
| Azienda Policlinico Umberto I, Universita La Sapienza, Oncologia B | Roma | 00161 | Italy |
| Fondazione Policlinico Universitario Agostino Gemelli Unità di Farmacologia Clinica | Roma | 00168 | Italy |
| National Cancer Center Hospital East | Kashiwa | Chiba | 277-8577 | Japan |
| Osaka International Cancer Institute | Osaka | Osaka | 541-8567 | Japan |
| National Cancer Center Hospital | Chuo-ku | Tokyo | 104-0045 | Japan |
| Amsterdam University Medical Centre, location VUmc | Amsterdam | North Holland | 1081 HV | Netherlands |
| Erasmus Universitair Medisch Centrum | Rotterdam | South Holland | 3015 GD | Netherlands |
| Hospital Universitario Vall d'Hebron | Barcelona | 08035 | Spain |
| H.G.U. Gregorio Maranon | Madrid | 28009 | Spain |
| Clinica Universidad de Navarra | Madrid | 28027 | Spain |
| H.U. Fundación Jiménez DÃaz | Madrid | 28040 | Spain |
| Hospital Universitario Virgen de Valme | Seville | 41014 | Spain |
| Barts Health NHS Trust, St Bartholomew's Hospital | London | EC1A 7BE | United Kingdom |
| Sarah Cannon Research Institute UK | London | W1G 6AD | United Kingdom |
| FG001 | Cohort 2 (Ataxia Telangiectasia Mutated [ATM] Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Baseline analysis population included all enrolled participants who received at least 1 dose of study treatment.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Cohort 1 (BRCA 1/2 Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes were enrolled in Cohort 1. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
| BG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
| BG002 | 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 |
| |||||||||||||||
| Age, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | 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 | Percentage of Participants With Confirmed Objective Response (OR) as Assessed by Blinded Independent Central Review (BICR) | 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. | 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | 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 |
|
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | 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. | The safety analysis set included all enrolled participants who received at least 1 dose of study treatment. | Posted | Count of Participants | Participants | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With New or Worsening Hematology Laboratory Test Results During the On-Treatment Period | 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). | 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. | Posted | Count of Participants | Participants | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With New or Worsening Chemistry Laboratory Test Results During the On-Treatment Period | 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). | 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. | Posted | Count of Participants | Participants | From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately |
| |||||||||||||||||||||||||||||||
| Secondary | Serum Lowest (Trough) Concentration (Ctrough) of Avelumab | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | microgram(mcg)/milliliter(mL) | Predose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Serum Maximum Concentration (Cmax) for Avelumab | Cmax was defined as maximum observed plasma concentration. The determination method of Cmax was observing directly from data. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | mcg/mL | One hour post-dose on Day 1 of Cycles 1, 3, 6, 12, 18, 24 and Day 15 of Cycle 1 |
|
| |||||||||||||||||||||||||||||
| Secondary | Plasma Ctrough for Talazoparib | 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. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | picogram(pg)/mL | Predose on Cycle 1 Days 1, 15 and Cycle 3 Day 1 |
| ||||||||||||||||||||||||||||||
| Secondary | Plasma Post-dose Concentrations for Talazoparib | In this OM, the post-dose concentrations for talazoparib in plasma were reported. | 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. | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/mL | 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 |
|
| |||||||||||||||||||||||||||||
| Secondary | Number of Participants by Avelumab Anti-drug Antibody (ADA) Categories | 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. | 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. | Posted | Count of Participants | Participants | 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 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Neutralizing Antibodies (Nab) Levels Against Avelumab Ever-Positive | 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. | 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. | Posted | 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 |
| |||||||||||||||||||||||||||||||||
| Secondary | Percentage of Participants With Confirmed OR as Assessed by The Investigator | For participants with solid tumors, except mCRPC, OR was defined as a CR or PR per 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 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-PD, where PD was unequivocal progression of pre-existing lesions. | All efficacy analyses were performed based on the full analysis set. The full 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. | Posted | Number | 95% Confidence Interval | Percentage of participants | From the first dose of study treatment until the date of first documented disease progression or date of death from any cause, whichever comes first, assessed up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Tumor Response (TTR) as Assessed by BICR | For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a Best Overall Response (BOR) of CR or PR per RECIST v1.1. | The analysis population included all enrolled participants who received at least 1 dose of study treatment and with confirmed CR or PR as assessed by BICR. | Posted | Median | Full Range | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | TTR as Assessed by Investigator | For participants with solid tumors, except mCRPC: TTR was defined for participants with confirmed objective response (CR or PR) as the time from the first dose of study treatment to the first documentation of objective tumor response. For participants with mCRPC: TTR was defined as the time from the first dose of study treatment to the first objective evidence of soft tissue response with no evidence of confirmed bone disease progression on bone scan per PCWG3. Soft tissue response was defined as a BOR of CR or PR per RECIST v1.1. | The analysis population included all enrolled participants who received at least 1 dose of study treatment and with confirmed CR or PR as assessed by investigator. | Posted | Median | Full Range | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DoR) as Assessed by BICR | For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occured first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occured first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3. | The analysis population included all enrolled participants who received at least 1 dose of study treatment and with confirmed CR or PR as assessed by BICR. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | DoR as Assessed by Investigator | For participants with solid tumors, except mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first documentation of objective tumor response to the first documentation of objective tumor progression or to death due to any cause, whichever occurred first. For participants with mCRPC: DoR was defined for participants with confirmed objective response (CR or PR) as the time from the first objective evidence of soft tissue response (subsequently confirmed) per RECIST v1.1 and no evidence of confirmed bone disease progression by PCWG3 to the first subsequent objective evidence of radiographic progression or death due to any cause, whichever occurred first. Radiographic progression was defined as soft tissue progression evaluated per RECIST v1.1 or bone disease progression evaluated per PCWG3. | The analysis population included all enrolled participants who received at least 1 dose of study treatment and with confirmed CR or PR as assessed by investigator. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Progression Free Survival (PFS) as Assessed by BICR | For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first. | All efficacy analyses were performed based on the full analysis set. The full 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. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | PFS as Assessed by Investigator | For participants with solid tumors, except mCRPC: PFS was defined as the time from the first dose of study treatment to the date of disease progression by RECIST v1.1 or death due to any cause, whichever occurred first. For participants with mCRPC: PFS was defined as the time from the first dose of study treatment to documentation of radiographic progression in soft tissue evaluated per RECIST v1.1, in bone evaluated per PCWG3, or death, whichever occurred first. | All efficacy analyses were performed based on the full analysis set. The full 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. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Overall Survival (OS) for All Participants | OS was defined as the time from the first dose of study treatment to the date of death. Participants without an event (death) were censored at the date of last contact. | All efficacy analyses were performed based on the full analysis set. The full 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. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Prostate-Specific Antigen (PSA) Progression for Participants With mCRPC | For participants with mCRPC, time to PSA progression was defined as the time from the first dose to the date that a >=25% increase in PSA with an absolute increase of >=2 μg/L (2 ng/mL) above the nadir (or baseline for participants with no PSA decline) was documented, confirmed by a second consecutive PSA value obtained >=3 weeks (21 days) later. | The analysis population included all participants with mCRPC who received at least 1 dose of study intervention. | Posted | Median | 95% Confidence Interval | Months | Baseline up to approximately 24 months |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Confirmed PSA Response | For participants with mCRPC, PSA response was defined as confirmed PSA decline >=50% compared to baseline. PSA response was calculated as a decline from baseline PSA (ng/mL) to the maximal PSA response with a threshold of 50%. A PSA response must have been confirmed by a second consecutive value at least 3 weeks later. | The analysis population included all participants with mCRPC who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline up to approximately 24 months |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Circulating Tumor Cell (CTC) Count Conversion | For participants with mCRPC, CTC count conversion was defined as a decrease in CTC count from >=5 CTC per 7.5 mL of blood at baseline to <5 CTC per 7.5 mL of blood anytime on study. | The analysis population included all enrolled participants with mCRPC who received at least 1 dose of study treatment, and with CTC count >=5 CTC per 7.5 mL of blood at baseline. | Posted | Count of Participants | Participants | Day 1 of Cycle 1 to Cycle 4 |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Cancer Antigen 125 (CA-125) Response | For participants with ovarian cancer, CA-125 response was defined as at least a 50% reduction in CA-125 levels from baseline. The response must have been confirmed and maintained for at least 28 days. | The analysis population included all participants with ovarian cancer who received at least 1 dose of study intervention. | Posted | Count of Participants | Participants | Baseline, Day 1 of each treatment Cycle, maximum up to 4.3 years approximately |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Positive Programmed Death Ligand 1 (PD-L1) Expression in Baseline Tumor Tissue | PD-L1 expression on tumor and infiltrating immune cells was measured by immunohistochemistry (IHC). PD-L1 expression level was defined as the number of PD-L1 positive cells and/or qualitative assessment of PD-L1 staining on tumor and inflammatory cells in regions of interest. This OM reported the number of participants classified as positive according to scoring algorithms and cut-offs established from external sources. | The biomarker analysis set included all participants who received at least 1 dose of study treatment and had at least 1 screening biomarker assessment. | Posted | Count of Participants | Participants | Baseline |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Different Status for Defects in BRCA1, BRCA2 and ATM | Participants were enrolled in the two cohorts based on BRCA 1/2 and ATM defect status assessed by the local laboratory. The participant BRCA and ATM status was assessed retrospectively by central laboratory, that may differ from the status assessed by the local laboratory. The ATM participants with a negative ATM status per the central laboratory were reported to have a positive ATM status per the local laboratory. Therefore, participants with negative ATM status might have been included in the ATM defect cohort. For defects in BRCA1, BRCA2 and ATM by central laboratory analysis, participants were classified as positive, negative, not analyzable or missing. The number of participants in each category of BRCA 1 defect, BRCA 2 defect, BRCA 1 or BRCA 2 defect and ATM defect were presented. | The biomarker analysis set included all participants who received at least 1 dose of study treatment and had at least 1 screening biomarker assessment. | Posted | Count of Participants | Participants | Baseline |
| |||||||||||||||||||||||||||||||
| Secondary | Number of Participants by Status of Tumor Mutational Burden (TMB) at Baseline | TMB was defined as the total number of mutations in the tumor genome, or number of mutations per megabase of DNA if derived from targeted sequencing. TMB categories were defined as high, low for a number of mutations per megabase >=10 and <10, respectively. The TMB category 'Not analyzable' included participants with available samples but not evaluable. The TMB category 'Missing' included participants with no sample available. The number of participants in each category at only baseline were tabulated. | The biomarker analysis set included all participants who received at least 1 dose of study treatment and had at least 1 screening biomarker assessment. | Posted | Count of Participants | Participants | Baseline |
|
From baseline up to 30 days after last dose of study treatment, maximum up to 4.3 years approximately.
The same event may appear as both an AE and an SAE. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and nonserious event during the study. Total number at risk below refers to the number of participants evaluable for SAEs or AEs.
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 (BRCA 1/2 Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes were enrolled in Cohort 1. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. | 15 | 159 | 50 | 159 | 153 | 159 |
| EG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. | 3 | 41 | 7 | 41 | 40 | 41 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Bone marrow disorder | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Febrile neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Atrioventricular block second degree | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Eye disorder | Eye disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Intestinal obstruction | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Obstruction gastric | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Small intestinal perforation | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Small intestine polyp | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Subileus | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Disease progression | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cholecystitis | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Immune-mediated hepatitis | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Jaundice | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Liver injury | Hepatobiliary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal wall abscess | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Bacterial abdominal infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Clostridial infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Clostridium difficile colitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sepsis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Urosepsis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood alkaline phosphatase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Liver function test increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Troponin T increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Myositis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Osteitis | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Malignant neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Metastases to meninges | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neoplasm progression | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Depressed level of consciousness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Confusional state | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ureteric obstruction | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ureterolithiasis | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Urethral obstruction | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Urinary tract obstruction | Renal and urinary disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypothyroidism | Endocrine disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Ascites | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Asthenia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Chills | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Fatigue | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Infusion related reaction | Injury, poisoning and procedural complications | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood bilirubin increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| White blood cell count decreased | Investigations | MedDRA v25.1 | Non-systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hypokalaemia | Metabolism and nutrition disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cancer pain | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v25.1 | Non-systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA v25.1 | Non-systematic Assessment |
|
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 | Dec 16, 2021 | Mar 22, 2023 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D009477 | Hereditary Sensory and Autonomic Neuropathies |
| ID | Term |
|---|---|
| D009421 | Nervous System Malformations |
| D009422 | Nervous System Diseases |
| D020271 | Heredodegenerative Disorders, Nervous System |
| D019636 | Neurodegenerative Diseases |
| D011115 | Polyneuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D030342 | Genetic Diseases, Inborn |
Not provided
Not provided
| ID | Term |
|---|---|
| C000609138 | avelumab |
| C586365 | talazoparib |
Not provided
Not provided
Not provided
| 65 - <75 years |
|
| 75 - <85 years |
|
| >=85 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| American Indian or Alaska Native |
|
| Asian |
|
| White |
|
| Not reported |
|
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
| Participants |
|
|
|
|
|
|
Participants with locally advanced or metastatic solid tumors with one or more defects in the BRCA1 or BRCA2 genes were enrolled in Cohort 1. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
|
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication.
|
|
Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication.
|
|
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication.
|
|
Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| OG001 | Cohort 2 (ATM Defect) | Participants with locally advanced or metastatic solid tumors with one or more defects in the ATM gene without concurrent BRCA1/2 defect were enrolled in Cohort 2. Talazoparib was self-administered orally at a starting dose of 1 mg QD for participants with normal renal function or mild renal impairment until End of Treatment. Participants with moderate renal impairment received starting dose of 0.75 mg QD. Avelumab was administered as a 1-hour IV infusion Q2W on Days 1 and 15 of each 28-day cycle at a dose of 800 mg after administration of talazoparib and the premedication. |
|
|
|
|
| Not analyzable |
|
| Missing |
|
| Not analyzable |
|
| Missing |
|
| Not analyzable |
|
| Missing |
|