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Checkpoint Inhibitor

Triple Therapy for Small Cell Lung Cancer

Phase 1 & 2
Waitlist Available
Led By Jyoti Malhotra, MD
Research Sponsored by Jyoti Malhotra
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Recovery to grade 1 of any clinically significant toxicity (excluding alopecia, grade 2 fatigue, vitiligo, endocrinopathies on stable replacement therapy) prior to initiation of study drugs
For male patients who are sexually active and who are partners of premenopausal women: agreement to use 2 forms of contraception as in criterion 9b above during the treatment period and for 31 weeks after the last dose of study drug
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment on patients who haven't responded to other treatments. It's divided into two parts, with the first part testing different doses to see what's safe and effective.

Who is the study for?
This trial is for adults over 18 with recurrent small cell lung cancer (SCLC) who have seen their disease progress after platinum-based chemotherapy. They must have tried a PD-1/PD-L1 therapy if entering Phase II, be in good health otherwise, and women of childbearing age must test negative for pregnancy and agree to use two forms of contraception.Check my eligibility
What is being tested?
The study tests Nivolumab, Ipilimumab, and Plinabulin in patients with SCLC that came back after first-line treatment. It's an open-label trial meaning everyone knows what treatment they're getting. The first phase checks the right dose while the second phase looks at how well these drugs work together.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation in different organs, skin issues, hormone gland problems (endocrinopathies), fatigue, digestive disturbances such as diarrhea or colitis, liver enzyme changes indicating potential liver damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have recovered from major side effects of previous treatments, except for hair loss, mild fatigue, skin color changes, or stable hormone issues.
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I am a man who agrees to use two forms of birth control during and for 31 weeks after treatment.
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My cancer returned or worsened within 3 months after platinum chemotherapy, and I've had PD-1/PD-L1 therapy.
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I am over 18 years old.
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My cancer is confirmed as extensive-stage small cell lung cancer.
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My cancer can be measured on scans taken within the last 28 days.
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I am a woman who could become pregnant and have a negative pregnancy test.
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It has been over 2 weeks since my last cancer treatment.
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I agree to use two effective birth control methods during and after the study.
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I can care for myself and doctors expect me to live at least 12 more weeks.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 36 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase I: Maximum Tolerated Dose (MTD)
Phase II: Progression-Free Survival (PFS)
Secondary outcome measures
1-year Overall Survival
6-Month Progression-Free Survival
Assess Adverse Events
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Phase II: nivolumab, ipilimumab, and plinabulinExperimental Treatment3 Interventions
On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (MTD from Phase I). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur .
Group II: Phase I (Dose Escalation): nivolumab, ipilimumab and plinabulinExperimental Treatment3 Interventions
On Day 1 in a 21-day cycle, all patients will receive nivolumab (1 mg/kg, IV), ipilimumab (3 mg/kg, IV) and plinabulin (escalating cohorts, IV). After 4 treatment cycles, ipilimumab will be discontinued and patients will continue treatment with nivolumab 240 mg and plinabulin every 2 weeks (maintenance period) until one of the end of treatment criteria occur. Plinabulin escalation is as follows: Level -1 : 13.5mg/m^2 Level 1 (start) : 20mg/m^2 Level 2 : 30mg/m^2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
2014
Completed Phase 3
~4750
Ipilimumab
2014
Completed Phase 3
~2670
Plinabulin
2017
Completed Phase 3
~280

Find a Location

Who is running the clinical trial?

Jyoti MalhotraLead Sponsor
Salma SabbourLead Sponsor
Bristol-Myers SquibbIndustry Sponsor
2,632 Previous Clinical Trials
4,126,583 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In how many different settings is this research being conducted?

"This study is being conducted out of several hospitals, including the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis, Indiana; the University of Minnesota in Minneapolis, Minnesota; and the University of Illinois Cancer Center in Chicago, Illinois."

Answered by AI

Are investigators still looking for people to enroll in this experiment?

"The listed information on clinicaltrials.gov suggests that this trial is still open to new participants. The study was first advertised on September 6th, 2018 with the most recent update being October 26th, 2022."

Answered by AI

What is the primary disease that Plinabulin seeks to alleviate?

"Plinabulin has applications in the treatment of anti-angiogenic therapy and malignant neoplasms. The medication can also help patients with unresectable melanoma or squamous cell carcinoma."

Answered by AI

What are we trying to learn from this clinical trial?

"The primary outcome of this study is the maximum tolerated dose (MTD) over a 36-month period. Secondary outcomes include assessing adverse events, proportion of subjects with confirmed objective response, and clinical benefit rate."

Answered by AI

What previous research has been conducted on Plinabulin?

"Plinabulin was first researched in 2009 at Texas Children's Hospital. There have been 368 completed studies on the medication since then and presently there are 798 active studies regarding plinabulin with many of these trials based out of Indianapolis, Indiana."

Answered by AI

How many people are being treated as part of this study?

"As this study requires 35 individuals that satisfy the certain prerequisites, patients that meet these qualifications can enroll at various locations like the Indiana University Melvin and Bren Simon Cancer Center in Indianapolis or the University of Minnesota in Minneapolis."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
Moffitt Cancer Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
~6 spots leftby Apr 2025