Intratumoral Cavrotolimod Combined With Pembrolizumab or Cemiplimab in Patients With Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors
Public ClinicalTrials.gov record NCT03684785. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
Merkel Cell Carcinoma, Cutaneous Squamous Cell Carcinoma, or Other Advanced Solid Tumors: A Phase 1b/2 Study of Cavrotolimod Combined With Pembrolizumab or Cemiplimab
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a phase 1b/2, open-label, two-part, multicenter trial designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary efficacy of intratumoral cavrotolimod injections alone and in combination with intravenous pembrolizumab or cemiplimab in patients with Merkel Cell Carcinoma, cutaneous squamous cell carcinoma, and advanced solid tumors. Phase 1b of this trial is a 3+3 dose escalation study evaluating escalating or intermediate dose levels of cavrotolimod given with a fixed dose of pembrolizumab. The Phase 2 dose expansion part of the study will consist of two primary cohorts of patients: Merkel cell carcinoma and cutaneous squamous cell carcinoma. Patients in the Merkel Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of pembrolizumab while the Cutaneous Squamous Cell Carcinoma cohort will receive IT cavrotolimod combined with a fixed, standard dose of cemiplimab. The Phase 2 dose expansion is designed to provide a preliminary estimate of efficacy in patients that have progressed on an anti-PD-(L)1 CPI.
Study identification
- NCT ID
- NCT03684785
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1, Phase 2
- Enrollment
- 57 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Dec 13, 2018 (Actual)
- Primary completion
- Mar 30, 2022 (Actual)
- Completion
- Mar 30, 2022 (Actual)
- Last update posted
- Apr 7, 2022
2018 – 2022
United States locations
- U.S. sites
- 26
- U.S. states
- 19
- U.S. cities
- 24
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Arizona Cancer Center | Tucson | Arizona | 85719 | — |
| University of California Irvine | Orange | California | 92868 | — |
| UCSF Helen Diller Family Comprehensive Cancer Center | San Francisco | California | 94185 | — |
| John Wayne Cancer Institute / Providence St. John's Health Center | Santa Monica | California | 90401 | — |
| University of Colorado Cancer Center | Aurora | Colorado | 80045 | — |
| Western States Cancer Center | Englewood | Colorado | 80113 | — |
| Sylvester Comprehensive Cancer Center | Miami | Florida | 33136 | — |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | — |
| Holden Comprehensive Cancer Center | Iowa City | Iowa | 52242 | — |
| Norton Cancer Center | Louisville | Kentucky | 40241 | — |
| Dana Farber Cancer Institute | Boston | Massachusetts | 02215 | — |
| Washington University St. Louis | St Louis | Missouri | 63110 | — |
| Dartmouth-Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | — |
| Valley - Mount Sinai Comprehensive Cancer Center | Paramus | New Jersey | 07652 | — |
| Perlmutter Cancer Center | New York | New York | 10016 | — |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | — |
| Duke Cancer Institute | Durham | North Carolina | 27710 | — |
| University of Cincinnati | Cincinnati | Ohio | 45267 | — |
| Ohio State University Comprehensive Cancer Center | Columbus | Ohio | 43210 | — |
| Oregon Health and Science University | Portland | Oregon | 97239 | — |
| University of Pittsburgh Medical Center / Hillman Cancer Center | Pittsburgh | Pennsylvania | 15232 | — |
| Sammons Cancer Center | Dallas | Texas | 75246 | — |
| Baylor College of Medicine | Houston | Texas | 77030 | — |
| MD Anderson Cancer Center | Houston | Texas | 77030 | — |
| University of Washington- Seattle Cancer Care Alliance | Seattle | Washington | 98109 | — |
| West Virginia Cancer Institute | Morgantown | West Virginia | 26506 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT03684785, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 7, 2022 · Synced Oct 23, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT03684785 live on ClinicalTrials.gov.