Amivantamab in Patients With Metastatic/Recurrent Penile Squamous Cell Carcinoma

Sponsor
Latin American Cooperative Oncology Group
Study ID
NCT07808359
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Metastatic Penile Squamous Cell Carcinoma
  • Penile Squamous Cell Carcinoma

Eligibility Criteria

Sex
MALE
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • Amivantamab — DRUG
    Subcutaneous injection of amivantamab monotherapy administered in 21-day cycles: * Cycle 1 Day 1: 1,600 mg (2,240 mg if body weight is 80 kg or greater) * Cycle 1 Days 8 and 15: 2,400 mg (3,360 mg if body weight is 80 kg or greater) once weekly * Cycle 2 and beyond (Day 1): 2,400 mg (3,360 mg if body weight is 80 kg or greater) every 3 weeks (Q3W) Treatment continues up to 24 weeks, or until disease progression, unacceptable toxicity, or consent withdrawal.

Study Details

This is a collaborative, multicenter, open-label, Phase 2 clinical trial (APOLO TRIAL / LACOG 2425) designed to evaluate the efficacy, safety, and tolerability of subcutaneous amivantamab monotherapy in adult patients with histologically confirmed recurrent or metastatic penile squamous cell carcinoma (PSCC). Eligible participants must have experienced disease progression on or after receiving at least one platinum-based chemotherapy regimen (with or without immunotherapy). The study allocates participants into two parallel non-randomized cohorts based on their human papillomavirus (HPV) status (HPV-positive and HPV-negative).

Key Dates

First listed
Sep 8, 2026
Start date
Nov 30, 2026
Status verified
Sep 2026
Primary completion
Feb 28, 2029
Completion
Nov 30, 2029

Study Design

Enrollment
58 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HPV Positive Cohort
    Male patients 18 years of age or older with histologically confirmed recurrent or metastatic penile squamous cell carcinoma (PSCC) who progressed on or after first-line platinum-based chemotherapy and have HPV-positive tumor status (determined by IHC for p16 or FISH).
  • Experimental: HPV Negative cohort
    Male patients 18 years of age or older with histologically confirmed recurrent or metastatic penile squamous cell carcinoma (PSCC) who progressed on or after first-line platinum-based chemotherapy and have HPV-negative tumor status (determined by IHC for p16 or FISH).

Primary Outcome Measure

Objective Response Rate (ORR) by Investigator Assessment [ Time Frame: Up to 24 weeks ]

Central Contacts

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