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The purpose of this study is to assess the safety and tolerability of mRNA-4106 monotherapy and of mRNA-4200 in combination with checkpoint inhibitor therapy in participants with solid tumors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 (Dose Escalation): mRNA-4106 Alone | Experimental | Participants will receive mRNA-4106 at a test dose as monotherapy. |
|
| Arm 2 (Dose Escalation): mRNA-4200 Alone and in Combination with Pembrolizumab | Experimental | Participants will receive mRNA-4200 as monotherapy, followed by mRNA-4200 in combination with pembrolizumab, and continuation of pembrolizumab alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mRNA-4106 | Biological | Intramuscular injection |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | For Arm 1: Days 1-21 and Arm 2: Days 1-42 | |
| Number of Participants With Treatment Emergent Adverse Events, Serious Adverse Events and Adverse Events of Special Interest | Up to 2 years and 3 months |
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Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other inclusion and exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| START Midwest | Grand Rapids | Michigan | 49546 | United States | ||
| START San Antonio |
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| Pembrolizumab |
| Biological |
Intravenous infusion |
|
| mRNA-4200 | Biological | Intramuscular injection |
|
| San Antonio |
| Texas |
| 78229 |
| United States |
| START Mountain Region | West Valley City | Utah | 84119 | United States |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D012008 | Recurrence |
| D009369 | Neoplasms |
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| 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 |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C582435 | pembrolizumab |
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