Amivantamab in Patients With Metastatic/Recurrent Penile Squamous Cell Carcinoma

NCT07808359 | Not Yet Recruiting Phase 2

• 1 other identifier: LACOG 2425
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Penile Squamous Cell Carcinoma; Metastatic Penile Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR) by Investigator Assessment

  Percentage of participants who achieve a Best Overall Response of Partial Response (PR) or Complete Response (CR) as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

  Up to 24 weeks

Secondary Outcomes (7)

• Objective Response Rate by Independent Central Review (ORR-ICR)

  Up to 24 weeks

• Disease Control Rate (DCR)

  Up to 24 weeks

• Duration of Response (DoR)

  Up to 12 months

• Progression-Free Survival (PFS)

  Up to 12 months

• Overall Survival (OS)

  Up to 12 months

Study Arms (2)

HPV Positive Cohort

EXPERIMENTAL

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).

Drug: Amivantamab

HPV Negative cohort

EXPERIMENTAL

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).

Drug: Amivantamab

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.

Also known as: JNJ-61186372

HPV Negative cohort; HPV Positive Cohort

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically confirmed diagnosis of penile squamous cell carcinoma.
• Metastatic or locally advanced disease not amenable to therapy of curative intent (e.g., surgery, radiotherapy, chemoradiotherapy) in the opinion of the investigator.
• Measurable disease per RECIST v1.1 as assessed by the local site investigator/radiologist. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Have received up to 2 lines of previous systemic therapy. Documented disease progression on or after first-line or second-line platinum-based chemotherapy for locally advanced/metastatic disease. Disease progression within 12 months of (neo) adjuvant chemotherapy completion is considered first-line of therapy. Previous anti-PD-1/anti-PD-L1 therapy is allowed.
• Participants must have tumor tissue available for HPV testing. HPV status will be determined by IHC for p16 or FISH (both are acceptable) assessed by the local laboratory or central laboratory. Note: A copy of the local test report documenting the HPV status must be included in the participant records and must also be submitted to the sponsor.
• Male participant aged at least 18 years and no more than 85 years at the time of signing the informed consent form.
• Male Participants (Reproductive Potential). If capable of producing sperm, the participant agrees to the following from the first dose of study intervention and for at least 120 days after the last dose:
• Refrain from donating sperm.
• Use a penile/external condom when engaging in penile-vaginal intercourse with a partner of childbearing potential who is not currently pregnant, PLUS the partner must use an additional highly effective contraceptive method. Note: A condom alone is not considered highly effective, as breakage or leakage may occur. If the participant is azoospermic (vasectomized or due to medical cause, documented by medical records, examination, or history), no contraception is required. Contraceptive use must be consistent with local regulations for participants in clinical studies. If local label requirements for amivantamab are more stringent, those must be followed.
• The participant (or legally acceptable representative, if applicable) provides written informed consent for the study.
• Life expectancy of at least 12 weeks in the opinion of the investigator.
• Willing and able to provide an archival tumor tissue sample or newly obtained core/incisional/excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred; newly obtained biopsies are preferred to archived tissue (minimum 10-15 unstained slides recommended).
• Adverse events due to previous anticancer therapies must have recovered to ≤ Grade 1 or baseline (except for alopecia and vitiligo). Participants with endocrine-related AEs adequately managed on stable hormone replacement therapy are eligible.
• Adequate organ function defined by the laboratory values in Table 2 (specimens collected within 14 days prior to the start of study intervention). This population definition ensures a homogeneous group of platinum-refractory patients with measurable disease while maintaining broad applicability across age, race, and ethnicity, in line with the orphan nature of the disease and the universal EGFR overexpression observed in penile squamous cell carcinoma.
• Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. Evaluation is to be performed within 7 days prior to the start of study intervention.

You may not qualify if:

• History of interstitial lung disease (ILD)/pneumonitis/pulmonary fibrosis that required systemic steroids, or current ILD/pneumonitis (including radiation pneumonitis).
• Any evidence of active or suspected ILD/pneumonitis/pulmonary fibrosis on screening chest imaging (CT preferred).
• Participant with untreated brain metastases Note: Participants with definitively, locally treated metastases that are clinically stable and asymptomatic for at least 8 weeks and who are off or receiving low-dose corticosteroid treatment (≤10 mg prednisone or equivalent) for at least 4 weeks prior to the first dose of study treatment are eligible.
• Participant has a medical history or known presence of leptomeningeal disease, or participant has spinal cord compression not definitively treated with surgery or radiation.
• Uncontrolled illness, including but not limited to (applicable to all participants):
• Diabetes.
• Ongoing or active infection (includes infection requiring treatment with antimicrobial therapy \[participants will be required to complete antibiotics 1 week prior to starting study treatment\]) or diagnosed or suspected viral infection.
• Active bleeding diathesis.
• Impaired oxygenation requiring continuous oxygen supplementation.
• Known allergies, hypersensitivity, or intolerance to excipients of amivantamab or rHuPH20 (refer to the IB).
• Participant has a history of clinically significant cardiovascular disease including, but not limited to the following:
• Prolonged QTcF interval \>480 msec or clinically significant cardiac arrhythmia or electrophysiologic disease (eg, placement of implantable cardioverter defibrillator or atrial fibrillation with uncontrolled rate). Note: Participants with cardiac pacemakers who are clinically stable are eligible.
• Uncontrolled (persistent) hypertension: systolic blood pressure \>180 mm Hg; diastolic blood pressure \>100 mm Hg.
• Congestive heart failure defined as NYHA Class III, IV or Hospitalization for congestive heart failure (any NYHA Class) within 6 months of the first dose of study treatment.
• Pericarditis/clinically significant pericardial effusion.

Sponsors & Collaborators

• Latin American Cooperative Oncology Group: lead
• Janssen Research & Development LLC/McNeil Panama: collaborator

Study Sites (1)

Futtura Oncologia - Hub de Pesquisa Clínica

Porto Alegre, Rio Grande do Sul, Rio Grande do Sul, Brazil

Location

MeSH Terms

Interventions

amivantamab

Study Officials

• Fernando Cotait Maluf

  Hospital Beneficência Portuguesa de São Paulo and Hospital Israelita Albert Einstein

  PRINCIPAL INVESTIGATOR

• Fernando Sabino

  Hospital Sírio-Libanês DF

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+55 (51) 3384.5334; lacog2425@lacog.group

Head of Operations

CONTACT

+55 (51) 3384.5334; laura.voelcker@lacog.group

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicenter, open-label, non-randomized phase II study with two parallel cohorts stratified by human papillomavirus (HPV) status: HPV-positive cohort and HPV-negative cohort. Each cohort will be recruited and analyzed independently using Simon's two-stage design

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

BR (1)