What side effects are associated with this type of intervention?

Common treatments for melanoma, such as immune checkpoint inhibitors like pembrolizumab and investigational immune modulators, are associated with immune-related adverse events (irAEs). These include dermatologic issues (rash, pruritus), gastrointestinal problems (diarrhea, colitis), hepatic effects (hepatitis), and endocrine disorders (thyroid dysfunction, adrenal insufficiency). Less common but severe side effects can include pneumonitis, nephritis, and myocarditis. Management typically involves immunosuppression with glucocorticoids or other agents.

What prior FDA approvals exist?

Pembrolizumab, a PD-1 inhibitor, has been FDA-approved for the treatment of advanced melanoma. It has shown efficacy in both monotherapy and combination therapy settings. Another PD-1 inhibitor, Nivolumab, has also been approved for melanoma treatment, often used in combination with Ipilimumab, a CTLA-4 inhibitor, to enhance therapeutic outcomes. These combinations have demonstrated improved overall survival and progression-free survival in clinical trials. The combination of Pembrolizumab with other agents, such as Lenvatinib, has also been explored and approved for other cancers, indicating a trend towards combination therapies in immuno-oncology.

What other types of research exist?

Promising alternatives to IMM60 + Pembrolizumab for melanoma patients include: 1) Nivolumab (PD-1 inhibitor) combined with Ipilimumab (CTLA-4 inhibitor), which has shown significant clinical benefits in metastatic melanoma. 2) Talimogene laherparepvec (T-VEC) combined with Pembrolizumab, which has demonstrated efficacy in advanced melanoma. 3) Adoptive T-cell transfer therapies and cancer vaccines, which are being actively investigated in clinical trials for their potential to provide durable responses.

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IMM60 + Pembrolizumab for Melanoma

Q: What is the mechanism of action of this treatment?

Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway to reactivate T-cells, enabling them to recognize and attack melanoma cells. IMM60, an investigational immune modulator, likely enhances the immune system's anti-tumor response. These mechanisms are vital for melanoma patients as they emphasize the role of immune activation in improving treatment outcomes and survival rates.

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.

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My melanoma's BRAF mutation status is known.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through phase 1 completion, an average of 1 year

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

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

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Pembrolizumab, a PD-1 inhibitor, blocks the PD-1 pathway to reactivate T-cells, enabling them to recognize and attack melanoma cells. IMM60, an investigational immune modulator, likely enhances the immune system's anti-tumor response. These mechanisms are vital for melanoma patients as they emphasize the role of immune activation in improving treatment outcomes and survival rates.

Targeted Therapy and Checkpoint Immunotherapy Combinations for the Treatment of Cancer.