IMM60 + Pembrolizumab for Melanoma

Recruiting at 14 trial locations
PC
Overseen ByPortage Clinical Trials
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug, IMM60, alone and with pembrolizumab in patients with advanced melanoma or non-small cell lung cancer. The goal is to see if this combination can improve survival by helping the immune system fight cancer more effectively.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Pembrolizumab for treating melanoma?

Pembrolizumab has been shown to improve survival and response rates in patients with advanced melanoma, as demonstrated in several clinical trials. It is effective in patients who have not responded to other treatments, like ipilimumab and BRAF/MEK inhibitors, and has an acceptable safety profile.12345

Is the combination of IMM60 and Pembrolizumab safe for humans?

Pembrolizumab, also known as KEYTRUDA, has been shown to be generally safe in humans, with common side effects including tiredness, rash, itching, and diarrhea. Some less common but serious side effects involve the immune system, such as inflammation of the lungs (pneumonitis), liver (hepatitis), or thyroid issues.16789

What makes the drug IMM60 + Pembrolizumab unique for treating melanoma?

The combination of IMM60 and Pembrolizumab is unique because it pairs a novel treatment (IMM60) with Pembrolizumab, a drug that blocks a protein called PD-1 on immune cells, helping them attack cancer cells more effectively. This combination aims to enhance the immune response against melanoma, potentially offering a new option for patients who have not responded to other treatments.124510

Eligibility Criteria

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.

Inclusion Criteria

I agree to use contraception and not donate sperm for 120 days after my last treatment dose.
My NSCLC has been tested for PD-L1 levels.
I have a tumor that can be measured and has not been treated with radiation.
See 7 more

Exclusion Criteria

I have received an organ or tissue transplant from another person.
You have a prolonged QT interval, uncontrolled high blood pressure, moderate or severe heart failure, or recent heart attack or frequent chest pain.
I have or had lung inflammation that needed steroids.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Dose Finding

Initial safety assessment and dose finding for IMM60 alone and in combination with pembrolizumab

Up to 6 cycles (each cycle is 3 weeks)
Every 3 weeks

Phase 2: Randomized Treatment

Participants receive IMM60 + pembrolizumab or pembrolizumab alone to assess progression-free survival

Up to 35 cycles (each cycle is 3 weeks)
Every 3 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months after last participant enrolled

Treatment Details

Interventions

  • IMM60
  • Pembrolizumab
Trial OverviewThe 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.
Participant Groups
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

iOx Therapeutics

Lead Sponsor

Trials
1
Recruited
1+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials
4,096
Recruited
5,232,000+
Chirfi Guindo profile image

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis profile image

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Findings from Research

Pembrolizumab (Keytruda) is the first anti-PD-1 therapy approved in the US for treating advanced malignant melanoma, specifically for patients who have progressed after prior treatments.
It is designed to target the PD-1 protein, enhancing the immune system's ability to fight cancer, and is currently under review for approval in the EU.
Pembrolizumab: first global approval.Poole, RM.[2021]
Pembrolizumab is a monoclonal antibody that effectively blocks the PD-1 receptor on T cells, enhancing their ability to attack cancer cells, particularly in melanoma patients.
In a Phase I study involving 411 patients, pembrolizumab demonstrated high durable response rates with minimal toxicity, indicating its potential as a safe and effective treatment option for melanoma.
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma.Hersey, P., Gowrishankar, K.[2017]
In a post hoc analysis of the KEYNOTE-006 study involving 555 patients with advanced melanoma, both ipilimumab and BRAF ± MEK inhibitors showed antitumor activity as subsequent therapies after pembrolizumab, with overall response rates (ORR) of 17.5% for ipilimumab and 30.5% for BRAF ± MEK inhibitors.
Patients who had not previously received BRAF ± MEK inhibitors showed a significantly higher ORR of 43.2% when treated with these agents after pembrolizumab, indicating that prior treatment status may influence the effectiveness of subsequent therapies.
Antitumor activity of ipilimumab or BRAF ± MEK inhibition after pembrolizumab treatment in patients with advanced melanoma: analysis from KEYNOTE-006.Long, GV., Arance, A., Mortier, L., et al.[2022]

References

Pembrolizumab: first global approval. [2021]
Pembrolizumab joins the anti-PD-1 armamentarium in the treatment of melanoma. [2017]
Antitumor activity of ipilimumab or BRAF ± MEK inhibition after pembrolizumab treatment in patients with advanced melanoma: analysis from KEYNOTE-006. [2022]
Pembrolizumab for the treatment of thoracic malignancies: current landscape and future directions. [2017]
Pembrolizumab: A Review in Advanced Melanoma. [2022]
Real-world experience with pembrolizumab toxicities in advanced melanoma patients: a single-center experience in the UK. [2022]
Pembrolizumab in the management of metastatic melanoma. [2020]
FDA Approval Summary: Pembrolizumab for the Treatment of Patients with Unresectable or Metastatic Melanoma. [2022]
FDA Approval Summary: Accelerated Approval of Pembrolizumab for Second-Line Treatment of Metastatic Melanoma. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Clinical application effect of Pembrolizumab in the treatment of advanced cutaneous malignant melanoma. [2021]