Randomized Phase II Trial Neoadjuvant Nivolumab + Relatlimab (Opdualag) Versus Nivolumab for Resectable High-Risk Basal Cell Carcinoma
Overview
- Phase
- Phase 2
- Intervention
- Nivolumab
- Conditions
- Basal Cell Carcinoma
- Sponsor
- University of California, San Diego
- Enrollment
- 30
- Locations
- 3
- Primary Endpoint
- Pathologic response rate
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
Brief Summary
This is a Phase 2 clinical trial with a 2:1 randomization comparing neoadjuvant Nivolumab + Relatlimab (Opdualag) vs neoadjuvant Nivolumab in patients with resectable high risk basal cell carcinoma (HR BCC)
Detailed Description
Patients will be treated with 4 cycles of neoadjuvant Nivolumab + Relatlimab (Opdualag, cohort 1) or Nivolumab (cohort 2) given every 4 weeks followed by surgical resection. There will be an option to proceed directly to surgery after 2 cycles of therapy should patients have frank progression of disease based on clinical evaluation. There will also be an option to continue with Opdualag or Nivolumab beyond 4 cycles if there is ongoing clinical benefit per investigator discretion. If there is clinical evidence of a clinical complete response, patients may forgo surgery per investigator discretion. The primary outcome of pathologic response rate will be assessed at the time of resection. Patients will then be monitored for disease recurrence and other secondary outcomes.
Investigators
Soo Park
Medical Oncologist, Associate Professor of Medicine
University of California, San Diego
Eligibility Criteria
Inclusion Criteria
- •Ability to understand and the willingness to sign a written informed consent document.
- •Participants must have histologically or cytologically confirmed basal cell carcinoma.
- •Participants must have high risk BCC as defined by size 20 mm or greater in the head and neck region or 40 mm or greater for the trunk/extremities.
- •Participants must have surgically resectable BCC that is at increased risk for cosmetic disfigurement, functional defects, poor oncologic control, or anticipated to require skin grafting or free flap reconstruction per investigator assessment.
- •Participants must have treatment naive BCC.
- •Aged 18 years or older.
- •Eastern Cooperative Oncology Group Performance Status 0 or 1
- •Demonstrates adequate organ function as defined below:
- •Adequate bone marrow function
- •Absolute neutrophil count ≥ 1,500/microliter
Exclusion Criteria
- •Is currently receiving any other investigational agents.
- •Has participated in a study of an investigational product and received study treatment or used an investigational device within 4 weeks of the first dose of study treatment.
- •Hypersensitivity to Opdualag, nivolumab, or any of their excipients.
- •Presence of untreated (symptomatic) central nervous system metastases.
- •Presence of leptomeningeal metastatic disease.
- •Treatment with any live / attenuated vaccine within 30 days of first study treatment.
- •Radiation therapy within 2 weeks prior to first study treatment. Participants must have recovered (i.e., Grade ≤1 or at baseline) from radiation related toxicities prior to first study treatment.
- •Participants with a condition requiring systemic treatment with either corticosteroids (\> 10 mg daily prednisone equivalent) within 14 days or other immunosuppressive medications within 30 days of randomization. Note: Inhaled or topical steroids, and adrenal replacement steroid doses \> 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.
- •Participants with an active, known, or suspected autoimmune disease. Note: Participants with type I diabetes mellitus, hypothyroidism only requiring hormone replacement, skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •Prior allogeneic tissue/solid organ transplant.
Arms & Interventions
Cohort 2
Nivolumab 480 mg intravenous every 4 weeks, up to 4 cycles.
Intervention: Nivolumab
Cohort 1
Nivolumab 480 mg intravenous and Relatlimab 160 mg intravenous every 4 weeks, up to 4 cycles.
Intervention: Relatlimab plus Nivolumab
Outcomes
Primary Outcomes
Pathologic response rate
Time Frame: 2 years
The primary endpoint of this study is to evaluate the pathologic response rate (pathological complete response \[pCR\] plus major pathological response \[MPR\])) and the clinical complete response rate of Opdualag and Nivolumab in patients with resectable High-Risk Basal Cell Carcinoma.
Clinical complete response rate
Time Frame: 2 years
Clinical complete response rate, per World Health Organization (WHO) Clinical Response Criteria for externally visible tumor(s) which can only be assessed clinically with bidimensional measurements.