A Phase 2 Study of the Combination Dostarlimab With Niraparib In Patients With Penile Carcinoma Who Have Progressed Following Chemotherapy

H. Lee Moffitt Cancer Center and Research Institute2 sites in 1 country25 target enrollmentDecember 28, 2022

ConditionsPenile Carcinoma

InterventionsDostarlimab Niraparib

DrugsDostarlimab Niraparib

Overview

Phase: Phase 2
Intervention: Dostarlimab
Conditions: Penile Carcinoma
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Enrollment: 25
Locations: 2
Primary Endpoint: Overall Response Rate (ORR)
Status: Recruiting
Last Updated: 4 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

December 28, 2022

End Date

November 1, 2027

Last Updated

4 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Male

Investigators

Sponsor

H. Lee Moffitt Cancer Center and Research Institute

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Provide written, informed consent to participate in the study and follow the study procedures
•Histologically confirmed stage III (unresectable) or stage IV penile cancer, as per American Joint Committee on Cancer (AJCC) staging system.
•Life expectancy \>12 weeks
•Eastern Cooperative Oncology Group (ECOG) performance status of 0, or 1 (ECOG performance status 2 can be included after discussion with PI)
•Measurable disease per iRECIST
•Participants who have progressed or had tolerance problems to no more than one prior line of therapy in the locally advanced setting or post platinum-based chemotherapy, including in a neoadjuvant or adjuvant setting or in combination with radiation therapy.
•Participants must not have received any prior immune-oncology regimens, including but not limited to checkpoint inhibitors such as anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T cell co-stimulation or checkpoint pathways, indoleamine 2,3-dioxygenase pathway inhibitors, cancer vaccines, adoptive cell therapies, or other cytokine therapies
•Demonstrated adequate organ function, as defined in protocol, within 28 days of treatment initiation
•Clinically significant toxic effect(s) of the most recent prior chemotherapy must be Grade 1 or resolved (except alopecia and sensory neuropathy that may be Grade 2).
•If the participant received major surgery or radiation therapy of \> 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.

Exclusion Criteria

•Use of an investigational agent or an investigational device within 4 weeks or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, before administration of first dose of study drug.
•Active, known or suspected autoimmune disease requiring systemic treatment within the past 2 months or a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents. (Exceptions include any patient on 10 mg or less of prednisone or equivalent, patients with vitiligo, hypothyroidism stable on hormone replacement, Type I diabetes, Graves' disease, Hashimoto's disease, alopecia areata, eczema, or with PI approval.)
•History of allergy or hypersensitivity to study drug components
•History of organ transplant that requires use of immune suppressive agents
•Current active pneumonitis within 90 days of planned start of the study or a known history of interstitial lung disease, drug-related pneumonitis, or radiation pneumonitis requiring steroid treatment.
•Prior surgery or radiotherapy encompassing \>20% of the bone marrow within 14 days of therapy. Patients must have recovered from all radiation-related toxicities.
•Active infection requiring systemic therapy; a known history of active tuberculosis.
•Has known active hepatitis B virus (HBV) infection (e.g., hepatitis B surface antigen \[HBsAg\] reactive) or hepatitis C virus (HCV) infection (e.g., HCV ribonucleic acid \[RNA\] qualitative is detected)
•Has known immunodeficiency or active human immunodeficiency virus (HIV-1/2 antibodies) with CD 4 count \< 400 for in the past 6 months.
•Prolonged corrected QT interval (QTcF) \> 450 ms for men

Arms & Interventions

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.

Intervention: Dostarlimab

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.

Intervention: Niraparib

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

Time Frame: Up to 24 months

Overall response rate is defined as the number of patients with best overall response of complete response or partial response divided by total number of participants by immune Response Evaluation Criteria in Solid Tumors (iRECIST) 1.1.