A Phase 1/2 Pharmacokinetic Multi-tumor Study of Subcutaneous Formulation of Ipilimumab Monotherapy and in Combination With Subcutaneous Nivolumab
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
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
Inclusion Criteria:
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
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
Exclusion Criteria:
- History of allergy or hypersensitivity to study drug components
Part 1 Arm A: Advanced HCC
Part 2 Arm A:Metastatic NSCLC
- Participants with known ALK translocations and EGFR mutation that are sensitive to available targeted inhibitor therapy
Other inclusion/exclusion criteria apply.
Naples, 80131, Italy