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Monoclonal Antibodies

Talazoparib + Avelumab for Kidney Cancer

Phase 2
Waitlist Available
Led By Ritesh Kotecha, MD
Research Sponsored by Memorial Sloan Kettering Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Eastern Cooperative Group (ECOG) Performance Status 0-2
Measurable disease by RECIST v1.1
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study Summary

This trial will test whether combining avelumab with talazoparib can effectively treat metastatic renal cell carcinoma.

Eligible Conditions
  • Renal Cell Carcinoma
  • Kidney Cancer

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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You can do regular daily activities without limitations or with a little limitation due to your health condition.
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You have a disease that can be measured using a specific method called RECIST v1.1.
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You have been diagnosed with kidney cancer or a specific type of kidney cancer, and your diagnosis has been confirmed by a review from Memorial Sloan Kettering Cancer Center if your surgery and biopsy were done at a different hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
the objective response rate (ORR)
Secondary outcome measures
progression-free survival (PFS)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual)Experimental Treatment2 Interventions
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Group II: Talazoparib and Avelumab (FH- or SDH-deficiency)Experimental Treatment2 Interventions
All patients will receive combination treatment at the previously established recommended phase II dose, 800 mg avelumab every 2 weeks with 1 mg talazoparib daily, in 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Avelumab
2018
Completed Phase 2
~2450
Talazoparib
2021
Completed Phase 2
~2740

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,927 Previous Clinical Trials
591,388 Total Patients Enrolled
Ritesh Kotecha, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
2 Previous Clinical Trials
43 Total Patients Enrolled

Media Library

Avelumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04068831 — Phase 2
Renal Cell Carcinoma Research Study Groups: Talazoparib and Avelumab (VHL-deficiency) (Closed to Accrual), Talazoparib and Avelumab (FH- or SDH-deficiency)
Renal Cell Carcinoma Clinical Trial 2023: Avelumab Highlights & Side Effects. Trial Name: NCT04068831 — Phase 2
Avelumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04068831 — Phase 2

Frequently Asked Questions

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

Are there multiple locations in the city administering this clinical investigation?

"Seven distinct medical centres are currently recruiting for this trial, with Memorial Sloan Kettering Westchester in Harrison having all protocol activities and both Memorial Sloan Kettering Bergen in Montvale and Memorial Sloan Kettering Monmouth in Middletown hosting limited protocol activities. Additional sites have been identified as well."

Answered by AI

How many participants is this experiment recruiting?

"Affirmative. Clinicaltrials.gov hosts information that indicates the current recruitment of 44 patients from 7 medical centres for this trial, first posted on August 22nd 2019 and recently updated on December 21st 2021."

Answered by AI

Are there still openings for participation in this experiment?

"Published on clinicaltrials.gov, this medical experiment is actively seeking participants. It was initially shared on August 22nd 2019 and recently updated December 21st 2021."

Answered by AI

What health conditions is Avelumab typically administered to address?

"Avelumab is typically prescribed for treating advanced medical cases. This medication can also reduce the symptoms of brca1 gene, merkel cell carcinoma, and malignant neoplasms."

Answered by AI

What prior experiments have included Avelumab as a key element?

"Currently, 162 trials for Avelumab are in progress with 12 at the Phase 3 level. Though most of these tests take place near Boston, Massachusetts, 5461 sites worldwide provide testing services."

Answered by AI

Can you evaluate the security of utilizing Avelumab?

"There is preliminary evidence suggesting the safety of avelumab, thus it was given an estimated score of 2. This Phase 2 trial lacks data to prove efficacy."

Answered by AI
~3 spots leftby Mar 2025