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

Conditions

• Constitutional Mismatch Repair Deficiency Syndrome
• Hematopoietic and Lymphoid Cell Neoplasm
• Lynch Syndrome
• Recurrent Lymphoma
• Recurrent Malignant Solid Neoplasm
• Recurrent Neuroblastoma
• Recurrent Primary Central Nervous System Neoplasm
• Refractory Lymphoma
• Refractory Malignant Solid Neoplasm
• Refractory Neuroblastoma
• Refractory Primary Central Nervous System Neoplasm
• Xeroderma Pigmentosum

Eligibility Criteria

Sex

ALL

Age

12 Months - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Biospecimen Collection — PROCEDURE
  Undergo collection of tissue samples
• Ipilimumab — BIOLOGICAL
  Given IV
• Nivolumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

May 11, 2021

Status verified

Jun 2026

Primary completion

Jun 21, 2022

Completion

Jun 21, 2022

Study Design

Enrollment

0 participants (actual)

Allocation

NON_RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Arms

• Experimental: Dose level -1 (nivolumab)
  PART I: Patients undergo collection of tissue samples for TMB level. Patients with elevated TMB may be eligible for Part II. PART II: Patients receive nivolumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 26 cycles in the absence of disease progression or unacceptable toxicity.
• Experimental: Dose level 1 (nivolumab, ipilimumab)
  PART I: Patients undergo collection of tissue samples for TMB level. Patients with elevated TMB may be eligible for Part II. PART II: Patients receive nivolumab IV over 30 minutes and ipilimumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 23 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 30 days after last dose of study drug ]

Locations (7)

Find similar trials in Palo Alto, CA

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