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Brief Title: A Study Evaluating the Drug Levels of Iplimumab Given Under the Skin Alone and in Combination With Nivolumab in Multiple Tumor Types

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

INTRODUCTION

  • Org Study ID: CA209-76U
  • Secondary ID: N/A
  • NCT ID: NCT04311710
  • Sponsor: Bristol-Myers Squibb

BRIEF SUMMARY

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

  • Overall Status
    Terminated
  • Start Date
    June 25, 2020
  • Phase
    Phase 1
  • Study Type
    Interventional

PRIMARY OUTCOMES

Primary Outcome 1 - Measure:

Primary Outcome 1 - Timeframe: N/A

CONDITION

  • Tumor

ELIGIBILITY

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com.
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.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Bristol-Myers Squibb

Role: Study Director

Affiliation: Bristol-Myers Squibb

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION

Facility Status Contact

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