Amivantamab in Patients With Metastatic/Recurrent Penile Squamous Cell Carcinoma
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18-85
SponsorLatin American Cooperative Oncology Group
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Amivantamab
DrugSubcutaneous 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.
Treatment groups
58 Participants
are divided into 2 treatment groupsGroup A: HPV Positive CohortExperimental treatment 1 intervention
Group B: HPV Negative cohortExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Up to 24 weeksSecondary outcomes
1
Objective Response Rate by Independent Central Review (ORR-ICR)
Percentage of participants who achieve a confirmed PR or CR as assessed by Independent Central Review per RECIST v1.1.
Time frame
Up to 24 weeks2
Disease Control Rate (DCR)
Percentage of participants achieving Complete Response (CR), Partial Response (PR), or Stable Disease (SD) as assessed by investigator per RECIST v1.1.
Time frame
Up to 24 weeks3
Duration of Response (DoR)
Time from the first documented evidence of PR or CR to the date of first documented disease progression (per RECIST v1.1) or death due to any cause.
Time frame
Up to 12 months4
Progression-Free Survival (PFS)
ime from the date of enrollment to the date of first documented disease progression (radiographically per RECIST v1.1 or clinically) or death due to any cause, whichever occurs first.
Time frame
Up to 12 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Latin American Cooperative Oncology Group
Lead sponsor
Janssen Research & Development LLC/McNeil Panama
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: