Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients (CheckMate743)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 3

Conditions: Mesothelioma

Treatments: Drug: Pemetrexed; Biological: Nivolumab; Drug: Cisplatin; Biological: Ipilimumab; Drug: Carboplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT02899299

2016-001859-43 (EudraCT Number)

CA209-743

Details and patient eligibility

About

The purpose of this study is to test the effectiveness and tolerability of the combination of Nivolumab and Ipilimumab compared to Pemetrexed and Cisplatin or Carboplatin in patients with unresectable pleural mesothelioma.

Enrollment: 605 patients

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:

• Males and Females at least 18 years of age
• Histologically confirmed pleural malignant mesothelioma not eligible for curative surgery
• ECOG Performance status of 0 or 1
• Available tumor sample for testing
• Acceptable blood work

Exclusion Criteria:

• Primitive peritoneal, pericardial and tunica vaginalis testis mesotheliomas
• Prior chemotherapy for pleural mesothelioma
• Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2 oranti-CTLA-4 antibody
• History of other malignancy unless the subject has been disease-free for at least 3 years
• Active, untreated central nervous system (CNS) metastasis

Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

605 participants in 2 patient groups

Nivolumab and Ipilimumab

Experimental group

Description:

Specified dose on specified days

Treatment:

Biological: Ipilimumab

Biological: Nivolumab

Pemetrexed and Cisplatin (or Carboplatin)

Active Comparator group

Description:

Specified dose on specified days

Treatment:

Drug: Pemetrexed

Drug: Carboplatin

Drug: Cisplatin