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Checkpoint Inhibitor

Combination Immunotherapy for Small Cell Lung Cancer

Phase 2
Waitlist Available
Led By Anne Chiang, MD, PhD
Research Sponsored by Yale University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with measurable disease with at least one tumor site amenable to biopsy
Patients with ECOG performance status of 0 to 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 24 months
Awards & highlights

Study Summary

This trial is testing a new cancer treatment in patients who have already received chemotherapy for small cell lung cancer.

Who is the study for?
This trial is for patients with recurrent extensive stage small cell lung cancer (SCLC) after platinum-based chemotherapy. Eligible participants may have treated brain metastases, an ECOG performance status of 0 to 2, and measurable disease. Excluded are those with HIV/HBV/HCV, recent major surgery or trauma, pregnant or lactating women, active autoimmune diseases requiring treatment in the past 3 months, untreated symptomatic CNS metastases, and recent other treatments.Check my eligibility
What is being tested?
The study tests a combination immunotherapy using Ipilimumab and Nivolumab on SCLC patients who've had disease progression post-platinum therapy. It aims to assess changes in tumor immune cells ratio and clinical benefits from the treatment.See study design
What are the potential side effects?
Potential side effects include immune-related reactions such as inflammation in various organs including lungs (pneumonitis), liver (hepatitis), intestines (colitis), hormone glands (endocrinopathies), skin rash; fatigue; infusion reactions; increased risk of infections.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a tumor that can be biopsied.
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I can take care of myself and am up and about more than half of my waking hours.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 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
Change in the ratio of Teff/Treg cells
Secondary outcome measures
Duration of response
Progression-free survival
Response rate
Other outcome measures
Change in ctDNA
Change in tumor microenvironment

Trial Design

1Treatment groups
Experimental Treatment
Group I: Nivolumab and IpilimumabExperimental Treatment1 Intervention
Patients will be treated with nivolumab 1 mg/kg and ipilimumab 3 mg/kg, starting on Day 1. Patients will receive 4 doses of each nivolumab and ipilimumab and then will receive nivolumab 240 mg starting week 13 (day 85) every 2 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.

Find a Location

Who is running the clinical trial?

Yale UniversityLead Sponsor
1,847 Previous Clinical Trials
2,736,503 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,638 Previous Clinical Trials
4,128,489 Total Patients Enrolled
Anne Chiang, MD, PhD5.01 ReviewsPrincipal Investigator - Yale University
Yale University
1 Previous Clinical Trials

Media Library

Ipilimumab and Nivolumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03670056 — Phase 2
Small Cell Lung Cancer Research Study Groups: Nivolumab and Ipilimumab
Small Cell Lung Cancer Clinical Trial 2023: Ipilimumab and Nivolumab Highlights & Side Effects. Trial Name: NCT03670056 — Phase 2
Ipilimumab and Nivolumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03670056 — Phase 2

Frequently Asked Questions

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

Are investigators actively looking for new participants?

"The clinical trial, which was created on December 6th 2018, is not currently looking for new patients. Although this specific trial is unavailable, there are 2412 other medical trials that are still recruiting right now."

Answered by AI

Are there any short-term or long-term dangers associated with this immunotherapy treatment?

"While there is some data indicating that the immunotherapy drug combination of ipilimumab and nivolumab is safe, as this is only a Phase 2 trial, more information is needed to support its efficacy. Consequently, it received a score of 2."

Answered by AI

What other research has been conducted on the effectiveness of this immunotherapy drug combination?

"At this time, there are 796 clinical trials underway for the combination immunotherapy of ipilimumab and nivolumab. 86 of these studies have progressed to Phase 3 testing. The majority of these tests are happening in Pittsburgh, but there are 43299 other locations around the world where similar trials are taking place."

Answered by AI

What are the most popular reasons that doctors prescribe Ipilimumab and Nivolumab together?

"Ipilimumab and Nivolumab administered together create an immunotherapy cocktail that has been used to treat patients who have undergone anti-angiogenic therapy in the past. Additionally, this treatment can be used for those suffering from malignant neoplasms, unresectable melanoma, and squamous cell carcinoma."

Answered by AI

How many study participants are needed for this clinical trial?

"1616 other clinical trials for small cell lung cancer (sclc) and 796 studies for combination immunotherapy with ipilimumab and nivolumab are currently recruiting patients."

Answered by AI
~2 spots leftby Dec 2024