A Study to Test the Safety and Effectiveness of Nivolumab Combined With Daratumumab in Patients With Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, That Have Advanced or Have Spread

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Advanced Cancer

Treatments: Biological: Daratumumab; Biological: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03098550

2017-000367-33 (EudraCT Number)

CA209-9GW

Details and patient eligibility

About

The purpose of this study is to determine whether a combination of Nivolumab and Daratumumab is safe and effective when treating Pancreatic, Non-Small Cell Lung or Triple Negative Breast Cancers, that have advanced or have spread.

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

• Patients with metastatic or advanced solid tumors
• Women with histologically or cytologically confirmed triple negative breast carcinoma
• Participants with histologically or cytologically confirmed pancreatic adenocarcinoma
• Participants with histologically or cytologically confirmed Non Small Cell Lung Cancer (NSCLC)

Exclusion criteria

• Active brain metastases or leptomeningeal metastases.
• Any serious or uncontrolled medical disorder
• Prior malignancy active within the previous 3 years

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 2 patient groups

Immunotherapy Combination

Experimental group

Description:

TNBC and PAC participants who are deriving clinical benefit will continue to be treated with the nivolumab plus daratumumab combination therapy

Treatment:

Biological: Daratumumab

Biological: Nivolumab

Nivolumab Monotherapy

Experimental group

Description:

NSCLC patients who are deriving clinical benefit will be treated with nivolumab monotherapy

Treatment:

Biological: Nivolumab