A PHASE II, RANDOMIZED STUDY TO ASSESS MAINTENANCE THERAPY WITH CEMIPLIMAB VERSUS BEST SUPPORTIVE CARE AFTER 1ST LINE PLATINUM-BASED CHEMOTHERAPY IN ADVANCED/RECURRENT PENILE CANCER (BRAVA PENILE)

This is a phase II, randomized study which will enroll participants given 4 to 6 cycles of first-line platinum-based chemotherapy treatment for advanced penile SCC not amenable by curative surgical treatment (stages III-IV as per American Joint Committeeon Cancer - AJCC - 8th) recurrent and who did not progress at the end of these 4 to 6 cycles. Participants eligible for the study will be randomized between 4 and 8 weeks after the last chemotherapy cycle to receive: - Cemiplimab maintenance plus best supportive care: cemiplimab 350 mg IV every 3 weeks until week 24, disease progression, unacceptable toxicity or consent withdrawal. patients who continue to derive clinical benefit on the experimental arm may continue to receive treatment until week 48. - Best supportive care.

Study Overview

• Status: Not yet recruiting
• Conditions: Penile Cancer
• Intervention / Treatment: Drug: Cemiplimab

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Henrique A Helber, MD; Phone Number: +55 11982720592; Email: henrique.helber@einstein.br

Study Locations

• Brazil
  • SP
    • São Paulo, SP, Brazil
      • Hospital Israelita Albert Einstein

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1) Male participants. 2) At least 18 years old on the day of signing the informed consent. 3) Histologically confirmed diagnosis of penile squamous cell carcinoma, clinical stages III-IV or relapsed disease, not amenable of curative intent therapy - as per AJCC 8th edition. 4) Measurable disease (as per RECIST v1.1) prior to starting first-line chemotherapy. Lesions located in a previously irradiated area are deemed as measurable if progression has been shown in such lesions. 5) Previous chemotherapy performed in localized disease setting, with curative intent and platinum-based is allowed, provided that the time off this treatment is longer than 6 months. 6) Previous first-line chemotherapy should have been comprised of at least 4 cycles and no more than 6 platinum-based chemotherapy cycles. 7) No evidence of progressive disease after completing first-line chemotherapy (e.g., ongoing complete response (CR), (partial response) PR or stable disease (SD) as per RECIST v1.1 guidelines). 8) An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 or 2.

Exclusion Criteria:

1) History of allergy or hypersensitivity to the study drug components. 2) Persisting NCI CTCAE v5.0 Grade > 1 toxicity related to previous therapy; however, Grade ≤ 2 sensory neuropathy and Grade ≤ 2 chronic kidney disease are acceptable. 3) Previous immune therapy with IL-2, IFN-α, or anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-T cytotoxic lymphocyte related to antigen-4 (CTLA-4), or any other antibody or drug specifically targeted to T-cell co-stimulation or immune checkpoint pathways. 4) Untreated or active primary brain tumor, metastases to central nervous system, leptomeningeal disease or spinal cord compression. 5) History of allogenic organ transplant. 6) Ongoing or recent evidence (within 5 years) of significant autoimmune disease requiring treatment with systemic immunosuppressants. 7) History of other primary malignancy within the last 3 years, except locally curable cancers which have been apparently cured, such as skin basal- or squamous-cell cancer, superficial bladder cancer, breast carcinoma in situ or cervical carcinoma in situ. 8) Uncontrolled infection by human immunodeficiency virus, hepatitis B or C infection; or immunodeficiency diagnosis. 9) Have received a live vaccine within 4 weeks of the planned start of the study drug. 10) Have received any previous systemic biological therapy within 5 half-lives of the first study therapy dose. Exception: participants previously treated with bevacizumab,

cetuximab, rituximab or other non-immunomodulating antibodies with half-lives longer than 7 days are allowed after a discussion with the sponsor, if at least 28 days have elapsed since last treatment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention; Best supportive care.
Experimental: Experimental; Cemiplimab maintenance plus best supportive care: cemiplimab 350 mg IV every 3 weeks until week 24, disease progression, unacceptable toxicity or consent withdrawal. patients who continue to derive clinical benefit on the experimental arm may continue to receive treatment until week 48.	Drug: Cemiplimab; Cemiplimab maintenance plus best supportive care: cemiplimab 350 mg IV every 3 weeks until week 24, disease progression, unacceptable toxicity or consent withdrawal. patients who continue to derive clinical benefit on the experimental arm may continue to receive treatment until week 48.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival	From enrollment to 24 weeks

Collaborators and Investigators

• Sponsor: Hospital Israelita Albert Einstein

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: July 28, 2025
• First Submitted That Met QC Criteria: July 28, 2025
• First Posted (Actual): August 3, 2025

Study Record Updates

• Last Update Posted (Actual): August 3, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Male Urogenital Diseases; Penile Diseases; Penile Neoplasms; Antineoplastic Agents, Immunological; Antineoplastic Agents; Cemiplimab
• Other Study ID Numbers: 10014 (Other Identifier: CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No