Study on Pembrolizumab Alone or with CMP-001 for Treating Melanoma That Can Be Removed by Surgery
Sponsor: National Cancer Institute (NCI)
ClinicalTrials ID:NCT04708418
This clinical trial is testing whether the drug pembrolizumab, alone or combined with CMP-001, can improve treatment outcomes for patients with melanoma that can be surgically removed. The study aims to see if these treatments can help the immune system shrink tumors and prevent them from coming back.
Patient Parameters
| Parameter | Options |
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Program Overview
This study is exploring the effects of pembrolizumab, an immunotherapy drug, alone or in combination with CMP-001, in patients with melanoma that can be treated with surgery. Pembrolizumab helps the immune system attack cancer cells, while CMP-001 may enhance this effect. The goal is to see if these treatments can effectively shrink tumors and prevent them from returning.
Description
The study is divided into two groups:
Group A:
- Before Surgery: Patients receive pembrolizumab through an IV every 21 days for up to 3 cycles, unless the cancer worsens or side effects are too severe.
- Surgery: Patients undergo surgery 1-2 weeks after the last treatment cycle.
- After Surgery: Patients continue to receive pembrolizumab every 21 days for up to 16 cycles, unless the cancer worsens or side effects are too severe.
Group B:
- Before Surgery: Patients receive CMP-001 injections and pembrolizumab through an IV every 21 days for up to 3 cycles, unless the cancer worsens or side effects are too severe.
- Surgery: Patients undergo surgery 1-2 weeks after the last treatment cycle.
- After Surgery: Patients continue to receive pembrolizumab every 21 days for up to 16 cycles, unless the cancer worsens or side effects are too severe.
Throughout the study, patients will have CT or PET/CT scans and may have optional biopsies and blood samples taken. After treatment, patients will have follow-up visits for up to 10 years to monitor their health and any signs of cancer returning.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Must have a good overall health status (ECOG score of 0 or 1).
- Must have a confirmed diagnosis of melanoma that can be surgically removed.
- Must be a candidate for surgery and have consulted with a surgical oncologist.
- Must not have received any live vaccines within 30 days before starting the study.
- Must have measurable disease that can be injected, as confirmed by recent scans.
- Must have adequate blood counts and organ function based on recent tests.
- Women must not be pregnant or breastfeeding and must agree to use effective contraception.
- Must not have received prior systemic therapy for melanoma.
- Must not have a history of severe allergic reactions to pembrolizumab.
- Must not have active infections or psychiatric conditions that would interfere with the study.
- Must not have a history of brain metastases or certain autoimmune disorders.
- Must not have had an organ transplant or a history of pneumonitis requiring steroids.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Anchorage Associates in Radiation Medicine | 98508 | Anchorage | Alaska |
| Alaska Breast Care and Surgery LLC | 99508 | Anchorage | Alaska |
| Alaska Oncology and Hematology LLC | 99508 | Anchorage | Alaska |
| Alaska Women's Cancer Care | 99508 | Anchorage | Alaska |
| Anchorage Oncology Centre | 99508 | Anchorage | Alaska |
| Katmai Oncology Group | 99508 | Anchorage | Alaska |
| Providence Alaska Medical Center | 99508 | Anchorage | Alaska |
| Fairbanks Memorial Hospital | 99701 | Fairbanks | Alaska |
| Banner University Medical Center - Tucson | 85719 | Tucson | Arizona |
| University of Arizona Cancer Center-North Campus | 85719 | Tucson | Arizona |
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