Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT05526989
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Penile Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dostarlimab — DRUG
    300 mg Dostarlimb will be administered by IV, increasing to 1000 mg after cycle 4.
  • Niraparib — DRUG
    200 mg Niraparib will be taken once daily by mouth days 1-21 of all cycles.

Study Details

The purpose of the study is to evaluate the efficacy and safety of the combination of niraparib and dostarlimab in patients participants with advanced relapsed/refractory penile cancer.

Key Dates

Start date
Dec 28, 2022
Status verified
Dec 2025
Primary completion
Nov 30, 2026
Completion
Nov 30, 2027

Study Design

Enrollment
25 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Dostarlimab and Niraparib treatment
    Participants will be given 500 mg Dostarlimab IV every 3 weeks for 4 cycles followed by 1000 mg every 6 weeks, along with 200 mg Niraparib by mouth once daily days 1-21 of all cycles.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 24 months ]

Locations (2)

FacilityCityStateZIPSite coordinators
Moffitt Cancer CenterTampaFlorida33612
Robin Neubauer
[email protected]
813-745-5604
Juskaran Chadha, DO (PRINCIPAL_INVESTIGATOR)
Monica Chatwal, MD (SUB_INVESTIGATOR)
Jingsong Zhang, MD, PhD (SUB_INVESTIGATOR)
MD Anderson Cancer CenterHoustonTexas77030
Curtis Pettaway, MD
[email protected]
713-792-3250
Curtis Pettaway, MD (PRINCIPAL_INVESTIGATOR)

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