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Monoclonal Antibodies

Avelumab Phase 1b for Avelumab and Talazoparib Therapy

Phase 1 & 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to at least a 50% reduction in ca-125 level (maximum up to 5.2 years approximately)
Awards & highlights

Study Summary

This trial will investigate if avelumab in combination with talazoparib can help treat patients with various types of solid tumors.

Eligible Conditions
  • Avelumab and Talazoparib Therapy

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to at least a 50% reduction in ca-125 level (maximum up to 5.2 years approximately)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to at least a 50% reduction in ca-125 level (maximum up to 5.2 years approximately) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1b: Number of Participants With Dose Limiting Toxicities (DLTs)
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per RECIST v1.1 and Prostate Cancer Working Group 3 (PCWG3) by Investigator Assessment
Phase 2: Percentage of Participants With Confirmed Objective Response (OR) as Per Response Evaluation Criteria in Solid Tumors (RECIST) Version (v) 1.1 by Investigator Assessment
Secondary outcome measures
Number of Participants With Different DNA Damage Repair (DDR) Status at Baseline
Number of Participants With Different Programmed Death-Ligand 1 (PD-L1) Status at Baseline
Number of Participants With Different Tumor Mutational Burden (TMB) at Baseline
+27 more

Trial Design

13Treatment groups
Experimental Treatment
Group I: F: Advanced Solid Tumors with BRCA or ATM defect Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group II: E2. CRPC DDR Defect +Assay Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group III: E1. CRPC Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group IV: Dose Level 0 Phase 1bExperimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group V: Dose Level -2 Phase 1bExperimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group VI: Dose Level -1 Phase 1bExperimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group VII: D.Urothelial CA Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group VIII: C2.Ovarian CA Recurrent Plat-Sensitive BRCA defect Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group IX: C1. Ovarian CA Recurrent Plat-Sensitive Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group X: B2. HR+BC DDR Defect +Assay Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group XI: B1. TNBC Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group XII: A2. NSCLC PD-L1 Resistant DDR+ Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib
Group XIII: A1. NSCLC Phase 2Experimental Treatment2 Interventions
Drug: Avelumab Drug: Talazoparib

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,915,803 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,476 Previous Clinical Trials
8,091,998 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What additional research into Avelumab Phase 1b has taken place?

"Currently, 162 trials are being conducted regarding the Phase 1b of Avelumab. Of these studies, 12 have progressed to Stage 3. Though most of them take place in Boston, Massachusetts there is a total 5461 locations running such investigations."

Answered by AI

What positive results are investigators anticipating from this trial?

"This medical trial will observe its main objective, overall response (OR), over the course of 28 days from first dose. Secondary goals include duration of response (DR) which is measured as time from initial tumor response to progression or death; genomic scarring and genetic defects in baseline tissue; and overall survival (OS) calculated by measuring time between drug administration and patient mortality."

Answered by AI

Are there any threats to patient safety associated with Avelumab Phase 1b?

"Avelumab Phase 1b received a score of 2 on our safety scale, as the evidence for its efficacy is still being gathered and verified from data collected during this phase 2 trial."

Answered by AI

Are there currently opportunities for participants to join in this research?

"As documented on clinicaltrials.gov, this medical study is not presently searching for candidates. Initially published on October 19th 2017 and last updated in late October 2022, the trial has no present openings; however there are currently 2542 other trials that are actively recruiting new participants."

Answered by AI

What ailments is Avelumab Phase 1b typically employed to treat?

"Avelumab Phase 1b is applied to treat advanced directives as well as certain genetic conditions such BRCA1, Merkel cell carcinoma, and malignant neoplasms."

Answered by AI

To what extent is enrollment limited for this research trial?

"Unfortunately, this clinical trial is no longer taking on new patients. It was made available in October 2017 and the most recent update to it took place in October 2022. For those looking for other studies related to cancer, there are 2380 active trials currently open as well as 162 Avelumab Phase 1b trials seeking participants."

Answered by AI

How many centers are offering this research trial?

"This clinical trial is operational in 34 sites, with USC/Norris Comprehensive Cancer Center/Investigational Drug Services located in Los Angeles, NYU Langone Medical Center found in New york and University Of Minesota Health: Clinics And Surgery Center situated in Minneapolis being just a few of them."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors
2017. "Javelin Parp Medley: Avelumab Plus Talazoparib In Locally Advanced Or Metastatic Solid Tumors". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03330405.
~30 spots leftby Apr 2025
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