for people ages 18 years and up (full criteria)
at San Francisco, California and other locations
study started
estimated completion
Principal Investigator
by Adil Daud
Photo of Adil Daud
Adil Daud



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

Official Title

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


Tumor lung cancer, renal cancer, bladder cancer, skin cancer, liver cancer Nivolumab Ipilimumab ENHANZE (rHuPH20)


For people ages 18 years and up

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit

Inclusion 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%

Exclusion Criteria:

  • History of allergy or hypersensitivity to study drug components

Part 1 Arm A: Advanced HCC

  • History of hepatic encephalopathy or evidence of portal hypertension
  • Active coinfection with hepatitis D virus infection in participants with HBV

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.


  • Local Institution not yet accepting patients
    San Francisco California 94158 United States
  • Fort Wayne Medical Oncology and Hematology accepting new patients
    Fort Wayne Indiana 46804 United States

Lead Scientist at UCSF

  • Adil Daud
    Immune therapy and Clinical Trials


accepting new patients
Start Date
Completion Date
Bristol-Myers Squibb
Phase 1/2
Study Type
Last Updated