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CBL0137 + Immunotherapy for Melanoma

Phase < 1

Waitlist Available

Led By Anthony Olszanski, MD

Research Sponsored by Fox Chase Cancer Center

Eligibility Criteria Checklist

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

Must have

ECOG performance status 0 or 1

Age > 18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 28 days

Awards & highlights

Study Summary

This trial assesses safety and activity of a new drug combo for advanced melanoma patients eligible for immunotherapy. Biopsies are taken for further study.

Who is the study for?

Adults over 18 with advanced melanoma, either stage III with lymph node metastases or stage IV, who can undergo biopsies. They must have good performance status and normal organ/marrow function. Not eligible if they're on other trials, have active autoimmune diseases, previous CTLA-4 or PD1/PD-L1 treatments, unresolved diarrhea, or need immunosuppressants.Check my eligibility

What is being tested?

The trial is testing CBL0137 combined with standard melanoma drugs Ipilimumab and Nivolumab. It's a phase I study to check safety and how the body responds to this mix of drugs in adults with serious melanoma that can be biopsied.See study design

What are the potential side effects?

Potential side effects may include typical reactions from immune therapies like inflammation in different parts of the body, fatigue, skin issues, digestive problems and changes in blood tests reflecting organ functions.

Eligibility Criteria

Inclusion Criteria

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

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I am fully active or can carry out light work.

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I am older than 18 years.

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I am willing to have more biopsies and blood tests for my condition.

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My organs and bone marrow are functioning normally.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Initial assessment of safety and tolerability of the combination of CBL0137 with Nivolumab and Ipilimumab.

Trial Design

3Treatment groups

Experimental Treatment

Group I: CBL0137 (Dose level 1) +Ipilimumab + NivolumabExperimental Treatment3 Interventions

Dose level 1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Group II: CBL0137 ( Dose level 2) +Ipilimumab + NivolumabExperimental Treatment3 Interventions

Dose level 2 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Group III: CBL0137 ( Dose level -1) +Ipilimumab + NivolumabExperimental Treatment3 Interventions

Dose level -1 CBL0137 on Days 1 and 8, Nivolumab and Ipilimumab on days 8 and 29 administrated IV of 8 weeks treatment cycles.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CBL0137

2013

Completed Phase 1

~90

Ipilimumab

2014

Completed Phase 3

~2620

Nivolumab

2014

Completed Phase 3

~4750

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fox Chase Cancer CenterLead Sponsor

227 Previous Clinical Trials

37,497 Total Patients Enrolled

2 Trials studying Melanoma

570 Patients Enrolled for Melanoma

IncuronIndustry Sponsor

3 Previous Clinical Trials

95 Total Patients Enrolled

1 Trials studying Melanoma

7 Patients Enrolled for Melanoma

Anthony Olszanski, MDPrincipal InvestigatorFox Chase Cancer Center

3 Previous Clinical Trials

124 Total Patients Enrolled

Media Library

CBL0137 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05498792 — Phase < 1

Melanoma Clinical Trial 2023: CBL0137 Highlights & Side Effects. Trial Name: NCT05498792 — Phase < 1

CBL0137 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05498792 — Phase < 1

Melanoma Research Study Groups: CBL0137 (Dose level 1) +Ipilimumab + Nivolumab, CBL0137 ( Dose level 2) +Ipilimumab + Nivolumab, CBL0137 ( Dose level -1) +Ipilimumab + Nivolumab

Frequently Asked Questions

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

Is this experimental research accepting new participants?

"Clinicaltrials.gov provides evidence that this experiment is still searching for participants, as it was originally posted on November 30th 2022 and revised on January 20th 2023."

Answered by AI

What is the maximum enrollment for this clinical experiment?

"Correct. The clinicaltrial.gov database reflects that this medical experiment, posted on November 30th 2022, is actively enrolling participants. There are 12 patients required for the trial to be conducted at a single center."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma

2022. "Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05498792.