WithdrawnPhase 1

Testing the Combination of Two Immunotherapy Drugs (Nivolumab and Ipilimumab) in Children, Adolescent, and Young Adult Patients With Relapsed/Refractory Cancers That Have an Increased Number of Genetic Changes, The 3CI Study

Stopped: Inadequate accrual rate

United States, Canada0Started 2021-05-11

Plain-language summary

This phase Ib trial investigates the side effects of the combination of nivolumab and ipilimumab, and to see how well they work in treating patients with cancers that have come back (relapsed) or does not respond to treatment (refractory) and have an increased number of genetic changes. Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Tumor mutational burden (TMB) is the total amount of genetic changes or "mutations" found in tumor cells. Some studies in adults with cancer have shown that patients with a higher TMB (an increased number of genetic changes) are more likely to respond to immunotherapy drugs. There is also evidence that nivolumab and ipilimumab can shrink or stabilize cancer in adult patients with cancer. This study is being done to help doctors learn if the combination of nivolumab and ipilimumab can help children, adolescents, and young adults patients live longer.

Who can participate

Age range

12 Months – 25 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * PART 1: Patients must have histologically or cytologically confirmed malignancy at the time of initial diagnosis, relapse, or recurrence. Patients must have recurrent or refractory cancer for which standard curative or palliative measures do not exist or are no longer effective * Patients with multiple concurrent and/or sequential neoplasms are eligible * Patients with central nervous system (CNS) tumors are eligible, except those with diffuse intrinsic pontine glioma * Patients with lymphoma are eligible; patients with leukemia are excluded * Chemotherapy-naive patients are eligible in cases where first-line therapy does not include chemotherapy (e.g., surgery only for ependymoma management) * PART 1: Patients must have evidence of one or more of the following criteria in current or previous tumor: * Microsatellite instability (MSI-H) * Mutation causing functional loss of mismatch repair gene expression (MLH1, MSH2, MSH6, PMS2, EPCAM, MSH3) * Hypermutation in any tumor (including primary malignancy for patients with relapse or previous cancer diagnoses) * Functional mutation of POLE or POLD1 genes * A syndrome linked to hypermutant cancer predisposition such as congenital mismatch repair deficiency (CMMRD), Lynch syndrome, or xeroderma pigmentosum (XP) is also permitted * Other factors or sequencing evidence not listed above but which may be predictive of hypermutant cancer may be permitted after discussion with the protocol princ…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial has been withdrawn — do you know why it was withdrawn, and does that affect whether nivolumab plus ipilimumab could still be an option for my child through a different study or off-label use?
2Since this was a Phase 1 trial focused primarily on measuring how often side effects occur rather than whether the treatment works, what does that tell us about how much is currently known about the safety and benefit of this combination in children and young adults with these cancers?
3My child's cancer involves a high number of genetic changes — possibly linked to conditions like Constitutional Mismatch Repair Deficiency or Lynch Syndrome — are there other open trials specifically targeting tumors with that kind of genetic profile that we should be looking into instead?
4Combining two immunotherapy drugs like nivolumab and ipilimumab can sometimes cause significant immune-related side effects — given my child's specific cancer type and current health, what risks would you be most concerned about with this kind of combination approach?
5Before considering an immunotherapy combination trial like this one, are there standard treatments we haven't yet tried that might be a better first step, or has the relapsed or refractory nature of the cancer changed that calculation?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of adverse events

Timeframe: Up to 30 days after last dose of study drug

Trial details

NCT IDNCT04500548

SponsorNational Cancer Institute (NCI)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2022-06-21

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