Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Basal Cell Carcinoma Clinical Trial

Official title: Nivolumab Alone or Plus Relatlimab or Ipilimumab for Patients With Locally-Advanced Unresectable or Metastatic Basal Cell Carcinoma

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Basal Cell Carcinoma
• Carcinoma
• Carcinoma, Basal Cell

• NCT number: NCT03521830
• Study type: Interventional
• Source: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
• Contact: Alice Pons, R.N., B. S, B.S.N.
• Phone: 410-502-9380
• Email: Ponsal@jhmi.edu
• Status: Recruiting
• Phase: Phase 2
• Start date: November 27, 2018
• Completion date: March 2027