Spots Global Cancer Trial Database for Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Study Description

Brief Summary: This is a phase 2 trial assessing the efficacy of nivolumab, alone or in combination with relatlimab or ipilimumab in treating patients with locally-advanced unresectable or metastatic basal cell carcinoma.

Detailed Description: This is an open-label, phase 2 signal-seeking study. Screening will begin by establishing a participant's initial eligibility and signing of the informed consent document. Eligible, enrolled patients will be assigned to one of 3 cohorts in a non-randomized fashion according to prior treatment history. Cohort A: Patients with advanced BCC (aBCC) who are treatment-naïve (i.e., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (Nivolumab) alone. Patients will receive Nivolumab 480mg IV every 4 weeks for up to 48 weeks (six 8-week cycles). Cohort B: Patients with advanced BCC who experience disease progression on anti-PD-1 (Nivolumab) + anti-LAG-3 (Relatlimab) will receive anti-PD-1 (Nivolumab) + anti-CTLA-4 (Ipilimumab). Patients will receive Nivolumab 240mg IV + Ipilimumab 1mg/kg IV every 3 weeks x 4 doses, then Nivolumab 480mg IV every 4 weeks x 7 doses starting 6 weeks after the final dose of Ipilimumab + Nivolumab. Cohort C: Patients with advanced BCC who experience disease progression on anti-PD-1 (on or off trial) will receive anti-PD-1 (Nivolumab) + anti-LAG-3 (Relatlimab). Patients will receive Nivolumab 480mg IV + Relatlimab 480mg IV every 4 weeks for up to 48 weeks (six 8-week cycles). Patients enrolled on Cohort A who demonstrate progressive disease after Nivolumab monotherapy may, if appropriate in the opinion of the investigator, move to Cohort B or Cohort C. Discontinuation of nivolumab or ipilimumab +nivolumab or relatlimab + nivolumab may be at the discretion of the investigator under circumstances including but not limited to the following: 1. A complete response to therapy. 2. A severe IMAR, defined as Grade 3 or greater. 3. Documented disease progression warranting alternative systemic therapy. 4. Intercurrent illness that prevents further administration of study treatment. 5. Noncompliance with trial treatment or procedure requirements, or administrative reasons.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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