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Nivolumab + Ipilimumab for Acute Myeloid Leukemia (CPIT-002 Trial)

Phase 1

Waitlist Available

Led By Andrew Pecora, MD

Research Sponsored by Hackensack Meridian Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up assess at 3, 6 and 12 months after transplant

Awards & highlights

CPIT-002 Trial Summary

This trial is testing a cancer treatment combining the drugs nivolumab with ipilimumab, to see if it is safe and effective for patients with acute myelogenous leukemia or myelodysplastic syndrome.

Who is the study for?

This trial is for adults under 71 with acute myeloid leukemia or high-risk myelodysplastic syndrome who are eligible for a bone marrow transplant from a matched donor. They must have good heart, liver, kidney, and lung function and not be pregnant or breastfeeding. Men and women must agree to use effective contraception.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of nivolumab alone, ipilimumab alone, or their combination after a bone marrow transplant in treating certain blood cancers. Participants will receive one of these immunotherapy drugs post-transplant to see how well they work.See study design

What are the potential side effects?

Nivolumab and ipilimumab can cause immune-related side effects such as inflammation in various organs including the intestines (colitis) and liver (hepatitis), skin issues (rash), hormone gland problems (like thyroid dysfunction), fatigue, infusion reactions, and increased risk of infections.

CPIT-002 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ assess at 3, 6 and 12 months after transplant

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~assess at 3, 6 and 12 months after transplant

This trial's timeline: 3 weeks for screening, Varies for treatment, and assess at 3, 6 and 12 months after transplant for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Safety: The occurrence of at least one treatment-related limiting toxicity defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE 4.0.

Secondary outcome measures

Neoplasms

Assess tumor site TCR repertoire using Poisson regression analysis with generalized estimating equations (GEE)

Assessment of blood TCR repertoire via TCR Immunoseq Assay Profiling

+6 more

CPIT-002 Trial Design

3Treatment groups

Experimental Treatment

Group I: Group C - Nivolumab + IpilimumabExperimental Treatment2 Interventions

Nivolumab 3 mg/kg for 12 doses, on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 Ipilimumab for 6 doses on day 1 of weeks 1, 4, 7, 10, 13, 16 Dose level 1: 0.3 mg/kg Dose level 2: 0.6 mg/kg Dose level 3: 1.0 mg/kg

Group II: Group B - IpilimumabExperimental Treatment1 Intervention

Ipilimumab for 6 doses on day 1 of weeks 1, 4, 7, 10, 13, 16 Dose level 1: 0.3 mg/kg Dose level 2: 1.0 mg/kg Dose level 3: 3.0 mg/kg

Group III: Group A - NivolumabExperimental Treatment1 Intervention

Nivolumab for 12 doses, on day 1 of weeks 1, 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34 Dose level 1: 1 mg/kg Dose level 2: 3 mg/kg

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

FDA approved

Ipilimumab

FDA approved

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Hackensack Meridian HealthLead Sponsor

131 Previous Clinical Trials

28,236 Total Patients Enrolled

Andrew Pecora, MDPrincipal InvestigatorHackensack UMC

James McCloskey, MDPrincipal InvestigatorHackensack UMC

Media Library

Nivolumab Clinical Trial Eligibility Overview. Trial Name: NCT02846376 — Phase 1

Acute Myeloid Leukemia Research Study Groups: Group B - Ipilimumab, Group C - Nivolumab + Ipilimumab, Group A - Nivolumab

Acute Myeloid Leukemia Clinical Trial 2023: Nivolumab Highlights & Side Effects. Trial Name: NCT02846376 — Phase 1

Nivolumab 2023 Treatment Timeline for Medical Study. Trial Name: NCT02846376 — Phase 1

Frequently Asked Questions

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

Are individuals aged 30 or above accepted into this research project?

"The eligibility requirements for this research specify that the minimum age is 18, with a maximum of 70 years old."

Answered by AI

Is this research venture presently recruiting participants?

"As of this moment, there are no longer any open positions for this clinical trial. It was initially posted on March 8th 2019 and last amended on August 5th 2022. However, if you still wish to participate in a medical study, 432 trials related to myelodysplastic syndromes remain active while 764 studies involving Ipilimumab continue recruiting new participants."

Answered by AI

Is Ipilimumab currently sanctioned by the FDA?

"Due to the limited data supporting its efficacy and safety, our team at Power assigned Ipilimumab a score of 1."

Answered by AI

What diseases has ipilimumab been employed to alleviate?

"Ipilimumab is commonly used to treat anti-angiogenic diseases and can also be beneficial when treating malignant neoplasms, inoperable melanomas, and squamous cell carcinoma."

Answered by AI

How many individuals are engaging in this research?

"This particular clinical trial has concluded its search for participants. The start date was March 8th, 2019 and the latest update was August 5th, 2022. For those looking to participate in other studies, there are 432 trials centered around myelodysplastic syndromes and 764 clinical trials focused on Ipilimumab still searching for candidates."

Answered by AI

Are there any other investigations involving Ipilimumab?

"Currently, there are over 700 active Ipilimumab studies with 86 of them being in the Phase 3 stage. While Pittsburgh is a hub for these trials, more than 42 thousand locations globally are offering this treatment as part of medical research."

Answered by AI

What criteria must an individual fulfill to participate in this clinical investigation?

"This medical trial is recruiting eight individuals with myelodysplastic syndromes ranging from 18 to 70 years old. Applicants must meet the following requirements: be eligible for an allogenic stem cell transplantation according to John Theurer Cancer Center at Hackensack University Medical Centre's Blood and Marrow Transplantation Program, have a cardiac ejection fraction above 50%, provided written consent in accordance with local regulations, fall within the specified age range on signing day, have a donor providing marrow or peripheral blood stem cells that match 6/6 (or 10/10 if unrelated) HLA-A, B, C DRB"

Answered by AI

Recent research and studies

Journal of Clinical PathologyJournal

Defective Neutrophil Function and Microbicidal Mechanisms in the Myelodysplastic Disorders.

Martin, S, S C Baldock, A T Ghoneim, and J A Child. 1983. “Defective Neutrophil Function and Microbicidal Mechanisms in the Myelodysplastic Disorders.”. Journal of Clinical Pathology. BMJ. doi:10.1136/jcp.36.10.1120.

Seminars in OncologyJournal

Immune Checkpoint Proteins: A New Therapeutic Paradigm for Cancer—preclinical Background: CTLA-4 and PD-1 Blockade

Weber, Jeffrey. 2010. “Immune Checkpoint Proteins: A New Therapeutic Paradigm for Cancer—preclinical Background: CTLA-4 and PD-1 Blockade”. Seminars in Oncology. Elsevier BV. doi:10.1053/j.seminoncol.2010.09.005.

CancerJournal

Targeting Cytotoxic T-lymphocyte Antigen-4 (CTLA-4)

O'Day, Steven J., Omid Hamid, and Walter J. Urba. 2007. “Targeting Cytotoxic T-lymphocyte Antigen-4 (CTLA-4)”. Cancer. Wiley. doi:10.1002/cncr.23086.

bifidobacteriumJournal