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IMM60 + Pembrolizumab for Melanoma

Phase 1 & 2
Waitlist Available
Research Sponsored by iOx Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
NSCLC cohorts: Histologically confirmed diagnosis of stage IV NSCLC
At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by RECIST 1.1 criteria
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through phase 1 completion, an average of 1 year
Awards & highlights

Study Summary

This trial is testing if a new combination of drugs can help people with advanced melanoma or non-small cell lung cancer.

Who is the study for?
This trial is for adults with advanced melanoma or stage IV non-small cell lung cancer (NSCLC) who are in good physical condition, have at least one measurable lesion, and proper organ function. NSCLC patients must not have certain gene mutations and need a PD-L1 assessment. Melanoma patients require known BRAF mutation status. Participants must agree to contraception use.Check my eligibility
What is being tested?
The study tests IMM60 alone or combined with pembrolizumab on participants with melanoma or NSCLC. Phase 1 focuses on safety and finding the right dose of IMM60. Phase 2 compares the effectiveness of IMM60 plus pembrolizumab against pembrolizumab alone in improving survival without disease progression after 12 months.See study design
What are the potential side effects?
Potential side effects may include immune system reactions, infusion-related responses, fatigue, changes in liver enzymes or blood counts indicative of organ inflammation, as well as an increased risk of infections due to immune modulation by both drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My lung cancer is at stage IV and has been confirmed by a biopsy.
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I have a tumor that can be measured and has not been treated with radiation.
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My lung cancer does not have certain genetic changes (no EGFR, ROS1 mutations, or ALK translocations).
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I am fully active or can carry out light work.
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My melanoma cannot be surgically removed and is either stage III or IV.
Select...
My melanoma's BRAF mutation status is known.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through phase 1 completion, an average of 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and through phase 1 completion, an average of 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Phase 1 Co-Primary Objective - Identify Maximum Tolerated Dose (MTD)
Phase 1 Co-Primary Objective - Safety
Phase 2 Primary Objective - Progression-free Survival
Secondary outcome measures
Objective Response Rate (ORR)
Pharmacokinetics of IMM60 - AUC (IMM60 arms only)
Pharmacokinetics of IMM60 - Cmax (IMM60 arms only)
+4 more

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab)Experimental Treatment2 Interventions
Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation safety cohorts.
Group II: Phase 2 PD-L1 <1% NSCLC Cohort 2Experimental Treatment2 Interventions
Participants will be treated with one cycle of IMM60 with a tumor biopsy before and after, to determine any changes in PD-L1 expression. After this one cycle, the participants will receive the combination of IMM60 IV for up to 6 total cycles + pembrolizumab 200 mg every 3 weeks administered IV. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts.
Group III: Phase 1 IMM60 dose escalation safety armExperimental Treatment1 Intervention
3 dose levels of IMM60 will be assessed (1, 3, 9 and 36 mg/m^2 administered IV every 3 weeks for up to 6 cycles)
Group IV: Phase 1 IMM60 + pembrolizumab combination safety armExperimental Treatment2 Interventions
Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles will be administered in combination with IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the IMM60 dose escalation safety cohort.
Group V: Melanoma CohortExperimental Treatment1 Intervention
IMM60 IV every 3 weeks for up to 6 cycles. The IMM60 dose will be determined based on the results of the Phase 1 dose escalation cohorts.
Group VI: Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, pembrolizumab monotherapy)Active Control1 Intervention
Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pembrolizumab
2017
Completed Phase 2
~2010

Find a Location

Who is running the clinical trial?

iOx TherapeuticsLead Sponsor
Merck Sharp & Dohme LLCIndustry Sponsor
3,886 Previous Clinical Trials
5,054,570 Total Patients Enrolled
120 Trials studying Melanoma
21,681 Patients Enrolled for Melanoma

Media Library

IMM60 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05709821 — Phase 1 & 2
Melanoma Research Study Groups: Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, pembrolizumab monotherapy), Phase 2 PD-L1 <1% NSCLC Cohort 2, Melanoma Cohort, Phase 1 IMM60 dose escalation safety arm, Phase 1 IMM60 + pembrolizumab combination safety arm, Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab)
Melanoma Clinical Trial 2023: IMM60 Highlights & Side Effects. Trial Name: NCT05709821 — Phase 1 & 2
IMM60 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05709821 — Phase 1 & 2

Frequently Asked Questions

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

Is enrollment for this research project still open?

"According to information provided on clinicaltrials.gov, this medical research project is no longer seeking participants as it was initially posted in April 15th 2023 and last updated on March 28th of the same year. Unfortunately, there are no more vacancies for this trial at present; however, 1011 other trials remain open to new applicants."

Answered by AI

Are there many locations in Canada where this experiment is currently being conducted?

"The recruitment of participants for this trial is taking place at Henry Ford Hospital - Internal Medicine in Detroit, Michigan, Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol in Badalona, Barcelona and Rutgers, The State University of New jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ) in New Brunswick. Additionally 14 other sites are being utilized."

Answered by AI

What primary goals is this clinical trial attempting to achieve?

"This clinical trial, measured at the end of each 28-day cycle for each patient, aims to assess safety as its primary objective. Secondary objectives include determining if IMM60 can restore sensitivity in PD-1 inhibitor resistant melanomas (phase 2), assessing response rate per RECIST 1.1 criteria, and determining Cmax and AUC concentrations for IMM60 arms only."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
IMM60 and Pembrolizumab in Melanoma and NSCLC
2023. "IMM60 and Pembrolizumab in Melanoma and NSCLC". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05709821.
~1 spots leftby Jun 2026
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