Multi-tumor CA209-764 (Phase I)

A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab.

A study evaluating the drug levels of ipilimumab alone and in combination with nivolumab applied under the skin in various tumor types.

Eligibility Criteria:

  • Men and women must follow methods of contraception as described in the protocol

Part 1 Arms A and B: Metastatic Melanoma

  • Previously untreated, histologically confirmed stage IV melanoma, as per American Joint Committee on Cancer (AJCC) staging system v.8.0

Part 1 Arm A: Advanced/mUC - Participants with histologically or cytologically confirmed urothelial carcinoma.

Part 1 Arm A: Advanced HCC

  • Participants with histological confirmation of Hepatocellular Cancer (HCC)

Part 2 Arm A: Metastatic NSCLC

  • Participants with histologically confirmed stage IV or recurrent Non Small Cell Lung Cancer (NSCLC)

Part 2 Arm B: Advanced or Metastatic RCC

  • Histological confirmation of Renal Cell Carcinoma (RCC)
  • ECOG Performance Status of 0 or 1 and for RCC (Part 2 Arm B), Karnofsky performance status ≥ 70%

Available at: Hartford Hospital

Cancer Clinical Research Office