The goal of this clinical trial is to learn about IMM60 with or without pembrolizumab in participants with advanced melanoma or non-small cell lung cancer. There are two phases: * Phase 1: This phase is designed to learn about the safety of IMM60 with or without pembrolizumab and to find a safe dose to test in Phase 2. * Phase 2: This phase is designed to learn whether IMM60 + pembrolizumab improves progression-free survival at 12 months compared to pembrolizumab alone in participants with non-small cell lung cancer.
This exploratory phase 1/phase 2 study is designed to establish a recommended phase 2 dose of IMM60 and provide preliminary estimates of safety and efficacy of IMM60 alone and in combination with pembrolizumab in participants with NSCLC and melanoma. In phase 1, initial safety will be assessed in a multiple dose escalation cohort for IMM60 alone, then for the IMM60 + pembrolizumab combination. Phase 2 of the study will recruit PD-1 pretreated melanoma participants and randomize PD-L1 \> 50% total NSCLC participants 2:1 to IMM60 + pembrolizumab vs pembrolizumab alone. There is an additional cohort of PD-L1 \< 1% NSCLC participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
1
IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion
Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion
USC Norris Comprehensive Cancer Center
Los Angeles, California, United States
Dana-Farber Cancer Institute - Medicine
Boston, Massachusetts, United States
Phase 1 Co-Primary Objective - Identify Maximum Tolerated Dose (MTD)
To confirm the maximum tolerated dose (MTD) of IMM60 alone and in combination with pembrolizumab, defined as the highest dose level at which \<2 out of 6 participants experience a dose-limiting toxicity
Time frame: Assessed at the end of Cycle 1 for each patient (each Cycle is 28 days)
Phase 1 Co-Primary Objective - Safety
To characterize the safety of IMM60 alone and in combination with pembrolizumab, as assessed by the frequency of Grade 3 or higher treatment-related adverse events
Time frame: Through Phase 1 completion, an average of 1 year
Phase 2 Primary Objective - Progression-free Survival
To compare the progression-free survival (PFS) rate at 12 months in the randomized arms comparing pembrolizumab alone versus IMM60 + pembrolizumab in patients with advanced PD-L1 ≥50% NSCLC
Time frame: 12 months after last participant enrolled
To characterize the safety of IMM60 alone or in combination with pembrolizumab
Frequency and severity of treatment-related adverse events (AEs)
Time frame: Through study completion, an average of 3 years
To determine if IMM60 can restore sensitivity in PD-1 inhibitor-resistant melanoma (phase 2)
Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in melanoma patients who have progressed on PD-1, and have added IMM60
Time frame: 12 months after last participant enrolled
Pharmacokinetics of IMM60 - Cmax (IMM60 arms only)
IMM60 maximal concentration (Cmax)
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Henry Ford Hospital - Internal Medicine
Detroit, Michigan, United States
Rutgers, The State University of New Jersey - Robert Wood Johnson Medical School - The Cancer Institute of New Jersey (CINJ)
New Brunswick, New Jersey, United States
Next VA
Fairfax, Virginia, United States
Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, Spain
Complexo Hospitalario Universitario A Coruña
A Coruña, Galicia, Spain
Hospital Xeral Álvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario 12 de Octubre
Madrid, Spain
...and 4 more locations
Time frame: During Cycles 1 and 3 (each Cycle is 28 days)
Pharmacokinetics of IMM60 - AUC (IMM60 arms only)
IMM60 area under the curve (AUC)
Time frame: During Cycles 1 and 3 (each Cycle is 28 days)
Objective Response Rate (ORR)
ORR is to be reported as the proportion of patients who have a Complete Response or Partial Response per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1
Time frame: 12 months after last participant enrolled
To determine if IMM60 can sensitize patients with programmed death-ligand 1 (PD-L1) <1% NSCLC to PD-1 inhibition
Objective response rate (ORR) per Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 in PDL1 \<1% NSCLC patients who receive IMM60 + pembrolizumab
Time frame: 12 months after last participant enrolled
To assess the ability of IMM60 to convert PD-L1 negative patients to PD-L1 positive
Percent of PD-L1 negative (\<1%) NSCLC tumors that increase PD-L1 gene expression following treatment with IMM60
Time frame: 12 months after last participant enrolled