NCT00527735
Completed
Phase 2
A Randomized, Double Blind, Parallel, Three Arm Trial Evaluating the Efficacy and Safety of Ipilimumab (BMS-734016) in Combination With Paclitaxel/Carboplatin Compared to Paclitaxel/Carboplatin Alone in Previously Untreated Subjects With Lung Cancer
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Bristol-Myers Squibb
- Enrollment
- 334
- Locations
- 25
- Primary Endpoint
- Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
Overview
Brief Summary
The purpose of the study is to determine whether ipilimumab given with paclitaxel/carboplatin has clinical benefit when compared with paclitaxel/carboplatin alone in patients with previously untreated lung cancer.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Histologically or cytologically confirmed lung cancer (Stage IIIb/IV nonsmall-cell lung cancer or extensive stage small-cell lung cancer \[SCLC\])
- •Measurable tumor lesion (as long as it is not located in a previously irradiated area) as defined by modified World Health Organization criteria
- •Eastern Cooperative Oncology Group performance status of ≤1 at study entry
- •Accessible for treatment and follow-up
Exclusion Criteria
- •Brain metastases
- •Malignant pleural effusion
- •Autoimmune disease
- •Motor neuropathy of autoimmune origin
- •SCLC-related paraneoplastic syndromes
- •Any concurrent malignancy other than nonmelanoma skin cancer; carcinoma in situ of the cervix or breast; or prostate cancer treated with systemic therapy (participants with a previous malignancy but without evidence of disease for 5 years were allowed to enter the study)
- •Prior systemic therapy for lung cancer. Prior radiation therapy or locoregional surgeries performed later than at least 3 weeks prior to randomization date were allowed.
- •Grade 2 peripheral neuropathy (motor or sensory)
- •Known HIV or hepatitis B or C infection
- •Chronic use of immunosuppressants and/or systemic corticosteroids (used in the management of cancer or noncancer-related illnesses). However, use of corticosteroids was allowed if used as premedication for paclitaxel infusion or for treating immune-related adverse events or adrenal insufficiencies.
Arms & Interventions
Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
Experimental
Intervention: Ipilimumab (Drug)
Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
Experimental
Intervention: Placebo (Drug)
Ipilimumab placebo + paclitaxel + carboplatin
Active Comparator
Intervention: Paclitaxel (Drug)
Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
Experimental
Intervention: Paclitaxel (Drug)
Ipilimumab/ placebo + paclitaxel + carboplatin (concurrent)
Experimental
Intervention: Carboplatin (Drug)
Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
Experimental
Intervention: Ipilimumab (Drug)
Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
Experimental
Intervention: Placebo (Drug)
Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
Experimental
Intervention: Paclitaxel (Drug)
Ipilimumab/ placebo + paclitaxel + carboplatin (sequential)
Experimental
Intervention: Carboplatin (Drug)
Ipilimumab placebo + paclitaxel + carboplatin
Active Comparator
Intervention: Placebo (Drug)
Ipilimumab placebo + paclitaxel + carboplatin
Active Comparator
Intervention: Carboplatin (Drug)
Outcomes
Primary Outcomes
Immune-related Progression-free Survival (irPFS) in Participants With Nonsmall-cell Lung Cancer (NSCLC) Per Immune-related Response Criteria (irRC)
Time Frame: Tumor assessed at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until immune-related Progressive Disease (irPD) or death (of censored, maximum reached: 16.5 months)
irPFS is defined as the time between the randomization date and date of immune-related Progressive Disease (irPD) (at least 25% increase percentage change in total tumor burden, including new lesions) or death, whichever occurs first. For patients with no recorded postbaseline tumor assessments, irPFS is censored at randomization. Participant who die without reported irPD are considered to have progressed on the date of death. For those who remain alive and have no irPD, irPFS is censored on the date of last evaluable tumor assessment. Independent review committee performed tumor assessment.
Secondary Outcomes
- Progression-free Survival (PFS) in Participants With NSCLC Per Modified World Health Organization (mWHO) Criteria(Randomization date to date of progression or death (of censored, maximum reached: 13.6 months))
- Overall Survival in Participants With NSCLC(Randomization date to date of death (of censored, maximum reached: 26.5 months))
- Best Overall Response Rate (BORR) Per mWHO Criteria in Participants With NSCLC and SCLC(Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance)
- Immune-related Best Overall Response Rate (irBORR) Per irRC in Participants With NSCLC and Small-cell Lung Cancer (SCLC)(Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance)
- Immune-related Disease Control Rate (irDCR) Per irRC and Disease Control Rate (DCR) Per mWHO Criteria in Participants With NSCLC and SCLC(Tumor assessment at screening, every 6 weeks on treatment to Week 24, and every 12 weeks on maintenance until irPD, progressive disease, or death (maximum reached: 22 months))
- Immune-related Duration of Response (irDoR) Per irRC and DoR Per mWHO Criteria in Participants With NSCLC and SCLC(Date of irCR or irPR to date of irPD or death (maximum reached: 14.2 months))
- Number of Participants With NSCLC Who Have Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, and Drug-related AEs by Worst Common Terminology Criteria (CTC) Grade(Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose))
- Percentage of Participants With NSCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade(At screening; predose Day 1; and Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent)
- irPFS in Participants With SCLC Per irRC(Randomization date to date of irPD or death (maximum reached: 22 months))
- Number of Participants With NSCLC Who Have Abnormalities in On-Study Liver Function Test Results By Worst CTC Grade(At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent)
- Number of Participants With NSCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings(At screening; Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until disease progression, study closure, or withdrawal of consent)
- Percentage of Participants With NSCLC Who Have Abnormalities in Pancreatic Enzyme Clinical Laboratory Test Results by Worst CTC Grade(At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment)
- Number of Participants With NSCLC Who Have Positive Human Antihuman Antibody (HAHA) Status Postbaseline(Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment)
- Number of Participants With SCLC With Death as Outcome, Serious Adverse Events (SAEs), Drug-related SAEs, Adverse Events (AEs), AEs Leading to Discontinuation, Drug-related AEs by Worst CTC Grade(Weeks 4, 7, 10, 16, 19, and 24; at end of treatment; and at follow-up (70 days from last dose))
- Number of Participants With SCLC Who Have Abnormalities in On-study Hematology Laboratory Test Results by Worst CTC Grade(At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment)
- Number of Participants With SCLC Who Have Abnormalities in Liver Function Test Results by Worst CTC Grade(At screening; predose Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment)
- Percentage of Participants With SCLC Who Have Abnormalities in Pancreatic Enzyme and Other Clinical Laboratory Test Results by Worst CTC Grade(At screening, predose Day 1, and Weeks 4, 7, 10, 13, 16, 19, 24, and at end of treatment)
- Progression-free Survival (PFS) in Participants With SCLC Per mWHO Criteria(Randomization date to date of progression or death (of censored, maximum reached: 22 months))
- Number of Participants With SCLC Who Had Abnormalities in Vital Sign Measurements and Physical Examination Findings(Predose Day 1; Weeks 4, 7, 10, 13, 16, and 24; and every 12 weeks on maintenance until end of treatment)
- Number of Participants With SCLC Who Have Positive HAHA Status Postbaseline(Day 1; Weeks 4, 7, 10, 13, 16, 19, and 24; and at end of treatment)
- Overall Survival in Participants With SCLC(Randomization date to date of death (of censored, maximum reached: 22 months))
Investigators
Study Sites (25)
Loading locations...
Similar Trials
Completed
Phase 3
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Plus Paclitaxel and Carboplatin Versus Placebo Plus Paclitaxel and CarboplatinLung Cancer (NSCLC)NCT02279732Bristol-Myers Squibb342
Completed
Phase 3
Phase 3 Trial in Squamous Non Small Cell Lung Cancer Subjects Comparing Ipilimumab Versus Placebo in Addition to Paclitaxel and CarboplatinLung Cancer - Non Small Cell SquamousNCT01285609Bristol-Myers Squibb1,289
Active, not recruiting
Phase 2
Ipilimumab With Carboplatin and Paclitaxel in Patients With Unresectable Stage III and Stage IV MelanomaUntreated Stage III Melanoma or Stage IV MelanomaNCT01676649Jewish General Hospital30
Completed
Phase 1
Drug-Drug Interaction - 3 Arm - Carboplatin/Paclitaxel, DacarbazineAdvanced MelanomaNCT00796991Bristol-Myers Squibb72
Recruiting
Phase 3
Pembrolizumab Plus Neoadjuvant Chemotherapy vs. Neoadjuvant Chemoradiotherapy for Locally Advanced ESCC (KEYSTONE-002)Esophageal Squamous Cell CarcinomaNCT04807673Tianjin Medical University Cancer Institute and Hospital342