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| ID | Type | Description | Link |
|---|---|---|---|
| KEYNOTE-E69 | Other Identifier | Merck Sharp & Dohme LLC | |
| 2022-003310-36 | EudraCT Number |
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Prioritization of other pipeline assets. No safety or efficacy issues were observed.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phase 1 IMM60 dose escalation safety arm | Experimental | 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) |
|
| Phase 1 IMM60 + pembrolizumab combination safety arm | Experimental | 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. |
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| Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, IMM60 + pembrolizumab) | Experimental | 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. |
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| Phase 2 PD-L1 ≥50% NSCLC Cohort 1 (Randomized, pembrolizumab monotherapy) | Active Comparator | Pembrolizumab 200 mg IV every 3 weeks for up to 35 cycles. |
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| Phase 2 PD-L1 <1% NSCLC Cohort 2 | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IMM60 | Drug | IMM60, every 3 weeks for up to 6 cycles, intravenous (IV) infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 12 months after last participant enrolled |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the safety of IMM60 alone or in combination with pembrolizumab | Frequency and severity of treatment-related adverse events (AEs) | Through study completion, an average of 3 years |
| To determine if IMM60 can restore sensitivity in PD-1 inhibitor-resistant melanoma (phase 2) |
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Inclusion Criteria:
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 to 1
Adequate organ function
At least 1 lesion, not previously irradiated, that can be accurately measured on CT or MRI as defined by RECIST 1.1 criteria
NSCLC cohorts: Histologically confirmed diagnosis of stage IV NSCLC
NSCLC cohorts: Patients with adenocarcinoma histology must not have sensitizing epidermal growth factor receptor (EGFR) or ROS proto-oncogene 1 (ROS1) mutations or anaplastic lymphoma kinase (ALK) translocations
NSCLC cohorts: Participants in NSCLC arms must have a PD-L1 assessment (PD-L1 immuno-histochemistry (IHC) 22C3 pharmDx)
Melanoma cohorts: Unresectable stage III or IV, histologically confirmed diagnosis of cutaneous or unknown primary melanoma
Melanoma cohorts: B-type Raf proto-oncogene (BRAF) mutation status available
Male participants: Participant must agree to use contraception and refrain from sperm donation during the treatment period and for at least 120 days after the last dose of study intervention
Female participants: Participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
Exclusion Criteria:
Has the following cardiac conditions:
Another active malignancy within the past 2 years (Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder, or carcinoma in situ [e.g., breast carcinoma, cervical cancer in situ] that have undergone potentially curative therapy are not excluded. Also, prostate, breast, and neuroendocrine tumors that are stable on hormonal treatment for a period of 1 year or more without the need to adjust dose are not excluded.)
Has had an allogeneic tissue/solid organ transplant
Known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are radiologically stable.
History of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
Participants with an active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids (in dosing exceeding 10 mg daily of prednisone equivalent) or immunosuppressive agents.
Participants who are known to be serologically positive for Hepatitis B, Hepatitis C, or human immunodeficiency virus.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| USC Norris Comprehensive Cancer Center | Los Angeles | California | 90033 | United States | ||
| Dana-Farber Cancer Institute - Medicine |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 4, 2026 | Mar 24, 2026 | 9 |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008545 | Melanoma |
| C565324 | Parkinson Disease 4, Autosomal Dominant Lewy Body |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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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.
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| Melanoma Cohort | Experimental | 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. |
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| Pembrolizumab | Drug | Pembrolizumab, 200 mg, every 3 weeks for up to 35 cycles or approximately 2 years, intravenous (IV) infusion |
|
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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 |
| 12 months after last participant enrolled |
| Pharmacokinetics of IMM60 - Cmax (IMM60 arms only) | IMM60 maximal concentration (Cmax) | During Cycles 1 and 3 (each Cycle is 28 days) |
| Pharmacokinetics of IMM60 - AUC (IMM60 arms only) | IMM60 area under the curve (AUC) | 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 | 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 | 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 | 12 months after last participant enrolled |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| Henry Ford Hospital - Internal Medicine | Detroit | Michigan | 48202 | 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 | 08901 | United States |
| Next VA | Fairfax | Virginia | 22031 | United States |
| Institut Català d'Oncologia-Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona | 08916 | Spain |
| Complexo Hospitalario Universitario A Coruña | A Coruña | Galicia | 15006 | Spain |
| Hospital Xeral Álvaro Cunqueiro | Vigo | Pontevedra | 36312 | Spain |
| Hospital de La Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Regional Universitario de Málaga | Málaga | 29011 | Spain |
| Hospital Universitario Virgen De La Macarena | Seville | 41009 | Spain |
| H. Clínico de Valencia | Valencia | 46010 | Spain |
| Nottingham University Hospital - Oncology | Nottingham | NG5 1PB | United Kingdom |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |