The purpose of this study is to determine whether an investigational combination immuno-therapy of nivolumab and daratumumab is safe and effective in thetreatment of advanced or metastatic solid tumors.

Phase 1

• Conditions: Advanced or metastatic solid tumors; MedDRA version: 20.0Level: PTClassification code 10061873Term: Non-small cell lung cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: LLTClassification code 10051971Term: Pancreatic adenocarcinomaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 20.0Level: PTClassification code 10075566Term: Triple negative breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2017-000367-33-ES
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-23
• Study Completion: 2020-07-02
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

- Patients must have metastatic or advanced solid tumors.
- Women with histologically or cytologically confirmed triple negative breast carcinoma.
- Participants with histologically confirmed pancreatic adenocarcinoma.
- Participants must have histologic or cytologic confirmation of Non Small Cell Lung Cancer (NSCLC).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 66
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 94

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified