A Safety Study of Nivolumab in Combination With Ipilimumab in Participants With Advanced Non-small Cell Lung Cancer (CheckMate 955)

Bristol-Myers Squibb (BMS)

Status and phase: Withdrawn; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Ipilimumab; Drug: Nivolumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT03048136

CA209-955

Details and patient eligibility

About

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Full description

A Study to Evaluate Safety in Participants with Chemotherapy-naïve Stage IV or Recurrent Non-small Cell Lung Cancer Treated With Nivolumab in Combination with Ipilimumab

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Inclusion Criteria:

• 1. Stage IV or recurrent non-Small cell lung cancer
• 2. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
• 3. Prior adjuvant or neoadjuvant chemotherapy for local, advanced disease allowed if completed at least 6 months prior to randomization

Exclusion Criteria:

• 1. Known epidermal growth factor receptor (EGFR) mutations or anaplastic lymphoma syndrome(ALK) translocations that are sensitive to targeted inhibitor therapy
• 2. Active, known or suspected autoimmune disease or HIV infection
• 3. Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors)
• 4. Untreated Central Nervous System metastases

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 2 patient groups

Flat-Dose

Experimental group

Description:

Nivolumab flat dose + Ipilimumab

Treatment:

Drug: Nivolumab

Drug: Ipilimumab

Weight-Based Dose

Experimental group

Description:

Nivolumab weight-based dose + Ipilimumab

Treatment:

Drug: Nivolumab

Drug: Ipilimumab