A Multicenter, Open-Label, Single-Arm, Phase II Clinical Trial to Evaluate the Efficacy and Safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma.
Overview
- Phase
- Phase 2
- Intervention
- Retifanlimab
- Conditions
- Penile Cancer
- Sponsor
- MedSIR
- Enrollment
- 18
- Locations
- 13
- Primary Endpoint
- Objective Response Rate (ORR)
- Status
- Completed
- Last Updated
- 11 months ago
Overview
Brief Summary
This is a multicenter, open-label, single-arm, phase II clinical trial to evaluate the efficacy and safety of INCMGA00012 in Advanced Penile Squamous Cell Carcinoma
Detailed Description
Men age ≥ 18 years with locally advanced unresectable or metastatic PSqCC stage 4 (i.e. T4 or N3 or M1) that are presenting with radiologic progression of disease (PD) following or not standard treatment with chemotherapy. After signing the ICF and confirmed eligibility, patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle, once every four weeks for up to 2 years. Patients will receive treatment until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment for any other reason. Patients discontinuing the study treatment period will enter a post-treatment follow-up period during which survival and new anti-cancer therapy information will be collected every 3 months (± 14 days) from the last dose of investigational product until the end of study (EoS).
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent form (ICF) prior to participation in any study-related activities.
- •Male patients ≥ 18 years of age at the time of signing ICF.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-
- •Life expectancy ≥12 weeks.
- •Histologically-proven PSqCC.
- •Locally advanced unresectable or metastatic stage 4 PSqCC that is not amenable to resection with curative intent (T4 or N3 or M1).
- •Radiological evidence of locally advanced or metastatic disease.
- •Patients must have measurable disease or evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v.)1.1 criteria.
- •Patients must agree to provide a tumor tissue sample from a metastatic site or the primary tumor at the time of study entry, with the exception of patients whom tumor biopsies cannot be obtained (e.g., inaccessible tumor or subject safety concern) that may submit an archived tumor specimen only upon agreement from the Sponsor. If feasible, patients will also be given the option of providing a tumor tissue sample at disease progression from metastasis or primary tumor (if tumor biopsies cannot be obtained for inaccessible lesion or subject safety concern).
- •Willingness and ability to provide blood samples (liquid biopsy) at the time of inclusion, after 2 cycles of study treatment (C3D1), and upon PD or study termination.
Exclusion Criteria
- Not provided
Arms & Interventions
Interventional arm
Patients will receive INCMGA00012 500 mg by intravenous infusion on Day1 of each cycle.
Intervention: Retifanlimab
Outcomes
Primary Outcomes
Objective Response Rate (ORR)
Time Frame: From baseline until disease progression or treatment discontinuation, up to 10.3 months
The primary efficacy endpoint for the study is the ORR. The ORR is defined as the number of patients with CR and PR divided by the number of patients in the analysis set. Tumor response will be defined as best response based on local investigator's assessment according to RECIST criteria v.1.1.
Secondary Outcomes
- Safety Adverse Events (AEs)(From baseline until disease progression or treatment discontinuation, up to 10.3 months)
- Efficacy Determined by Clinical Benefit Rate (CBR)(From baseline until disease progression or treatment discontinuation, up to 10.3 months)
- Efficacy Determined by Progression-free Survival (PFS)(From baseline until disease progression or treatment discontinuation, up to 10.3 months)
- Efficacy Determined by 6-months PFS(Baseline up to 6 months)
- Efficacy Determined by Duration of Response (DoR)(From baseline until disease progression or treatment discontinuation, up to 10.3 months)
- Efficacy Determined by Overall Survival (OS)(From baseline until disease progression or treatment discontinuation, up to 10.3 months)
- Efficacy Determined by Maximum Tumor Shrinkage(From baseline until disease progression or treatment discontinuation, up to 10.3 months)