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

[...] edule, laboratory tests, and other requirements of the study. Type of Participant and Target Disease Characteristics Eastern Cooperative Oncology Group (ECOG) Performance Status 0-21. Participants with histologically confirmed Basal Cell Carci [...] ered by the investigator to be unresectable or metastatic. i.) COHORT A: Patients with advanced BCC who haveare nottreatment-naïve received(i.e., no prior systemic therapy to treat BCC (e.g., hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 (nivolumab) alone. ii.) COHORT B: • Patients with advanced BCC who haveexperience re [...] [...]

[...] on according to prior treatment history. Cohort A: Patients whowith have not received prior systemic therapy to treatadvanced BCC (aBCC) who are treatment-naïve (i.e.g., no prior hedgehog pathway inhibitors and T cell modulating agents) will receive anti-PD-1 therapy(Nivolumab) or hedgehog signaling pathway inhibitors)alone. Patients will receive nivolumabNivolumab 480 mg480mg IV every 4 weeks for up to 48 weeks (six 8-week cycles). Cohort B: Patients whowith have refractoryadvanced BCC towho experience disease progression on anti-PD-(L)1 monotherapy (Cohort A or off studyNivolumab) and nivolu [...] [...]

[...] ed by the investigator to be unresectable or metastatic. i. ARMCOHORT A: patientsPatients maywith advanced BCC who have not received up to two prior systemic therapiestherapy includingto treat BCC (e.g., hedgehog pathway inhibitors and T cell modulating agents). ii. ARMCOHORT B: patientsPatients maywho have refractory BCC (defined as PD or ongoing SD at 36 weeks) after receiving anti-PD-(L)1 monotherapy on CA209-8DP (i.e., on Cohort A) or outside the study, and refractory BCC (defined as above) after relatlimab + nivolumab. Patients who have received up to two prior systemic therapies includin [...] [...]

[...] ent history. Cohort A: Patients who have not received prior anti-PD-1systemic therapy, but may have previously experienced progressive disease or intolerance after up to twotreat other systemic therapiesBCC (e.g., oneanti-PD-1 therapy or more hedgehog signaling pathway inhibitors) will receive nivolum [...] mg IV every 4 weeks for up to 48 weeks. Cohort B: Patients whosewho diseasehave hasrefractory progressedBCC afterto anti-PD-(L)1, eithermonotherapy as(Cohort a part of this trialA or outsideoff ofstudy) thisand trialnivolumab + relatlimab (Cohort C). Patients who have received prior hedgehog path [...] [...]