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Checkpoint Inhibitor

Combination Immunotherapy for Refractory Cancers

Phase 1

Recruiting

Led By Jibran Ahmed, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

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

Must have

Subjects must have normal organ and marrow function as defined

Age greater than or equal to 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cycle 1

Awards & highlights

Study Summary

This trial will test the effects and maximum dose of IL-15, nivolumab, and ipilimumab.

Who is the study for?

Adults (18+) with cancers that have spread and don't respond to treatment can join. They must be able to sign consent, not pregnant or breastfeeding, agree to use contraception, and have no severe illnesses or mental health issues that could interfere with the trial. Prior treatments are okay if recovered from side effects.Check my eligibility

What is being tested?

The trial tests a combination of immune-activating drugs: IL-15 plus nivolumab and/or ipilimumab in patients whose cancer hasn't responded to other treatments. It aims to find the highest safe dose by dividing participants into three groups receiving different drug combinations over four cycles.See study design

What are the potential side effects?

Possible side effects include reactions at injection sites, flu-like symptoms from IL-15; fatigue, skin rash, digestive issues from nivolumab; and colitis, hepatitis, skin problems from ipilimumab. Serious side effects may require stopping treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My organ and bone marrow functions are normal.

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I am 18 years old or older.

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I can take care of myself but might not be able to do heavy physical work.

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I have inactive brain metastases.

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My cancer is advanced, cannot be cured, and has no treatments that improve survival.

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I have at least one tumor that can be measured.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cycle 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cycle 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and cycle 1 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, toxicity profile, dose-limiting toxicity (DLT), and maximum tolerated doses (MTD)

Side effects data

From 2022 Phase 1 trial • 8 Patients • NCT03905135

100%

Alkaline phosphatase increased

50%

Localized edema

50%

Headache

50%

Cough

50%

Fatigue

50%

Fever

50%

Platelet count decreased

50%

Aspartate aminotransferase increased

50%

Edema limbs

50%

Hyponatremia

50%

Infusion related reaction

50%

Neutrophil count decreased

50%

Sinus tachycardia

50%

Somnolence

100%

80%

60%

40%

20%

Study treatment Arm

Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab

Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab

Trial Design

3Treatment groups

Experimental Treatment

Group I: tripletExperimental Treatment3 Interventions

triplet combination

Group II: lead-in doublet BExperimental Treatment2 Interventions

lead-in doublet for initial safety evaluation: rhIL-15 given SC days 1-8 and 22- 29 + nivolumab (anti-PD1) given IV on days 8, 22, and 36 (IL-15 doses are limited to first 4 cycles only)

Group III: lead-in doublet AExperimental Treatment2 Interventions

lead-in doublet for initial safety evaluation: rhIL-15 given SC days 1-8 and 22- 29 + ipilimumab (anti- CTLA-4) given IV on day 8 (IL-15 doses are limited to first 4 cycles only)

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Nivolumab

2014

Completed Phase 3

~4750

rhIL-15

2019

Completed Phase 1

~10