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NCT04708470 · ClinicalTrials.gov registry record · Phase 1
A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers
A Phase 1 study of Cervical Cancer and Colon Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 55
- Enrollment target
- 1
- Study location
NCT04708470: Active Phase 1 study of Cervical Cancer and Colon Cancer, sponsored by National Cancer Institute (NCI).
NCT04708470 is a Phase 1 study of Cervical Cancer and Colon Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 55 participants, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04708470, a Phase 1 study of Cervical Cancer and Colon Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 55 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Objective: To find a safe dose of entinostat in combination with PDS01ADC and bintrafusp alfa and to see if this treatment will cause tumors to shrink. Eligibility: Adults ages 18 and older who have cervical, oropharyngeal, anal, vulvar, vaginal, penile, squamous cell rectal, or another cancer that may be associated with HPV infection or microsatellite stable small bowel or colorectal cancer. Design: Participants will be screened with a medical history and physical exam. Their ability to do daily activities will be assessed. They may have imaging scans of the brain and/or chest, abdomen, and pelvis. They may have nuclear bone scans. They will have an electrocardiogram to test heart function. They will have blood and urine tests. They may have a tumor biopsy. Participants with skin lesions may have them photographed. Some screening tests will be repeated during the study. Treatment will be done in 28-day cycles. Participants will get bintrafusp alfa through an intravenous catheter every 2 weeks. They will get PDS01ADC as an injection under the skin every 4 weeks. They will take entinostat by mouth once a week. They will complete a medicine diary. Participants will get treatment for 2 years. They will have 1-2 follow-up visits in the 30 days after treatment ends. Then they will be contacted every 6 months to check on their health.
Primary Outcome
Phase II: To evaluate the objective response rate (ORR) according to Response Evaluation Criteria (RECIST 1.1) of the combination of entinostat, PDS01ADC, and bintrafusp alfa in two separate populations: checkpoint refractory HPV associated malignancies and MSS small bowel or colorectal cancer
Conditions Studied
Interventions
- DRUG Entinostat
- DRUG PDS01ADC
- DRUG Bintrafusp Alfa
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2021-10-05 |
| Est. Completion | 2026-11-30 |
| Phase | Phase 1 |
What the registry record for NCT04708470 still lists
NCT04708470 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 55 participants, a relatively small participant target, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (90% lower).
The record links to 10 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 3 interventions - of which Entinostat is the first listed.
NCT04708470 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04708470 about?
NCT04708470 is a clinical study titled "A Phase I/II Study of Combination Immunotherapy for Advanced Cancers Including HPV-Associated Malignancies, Small Bowel, and Colon Cancers". Background: Often, metastatic human papillomavirus (HPV) associated cancers cannot be cured. They also do not respond well to treatment. Some forms of colon cancer also have poor responses to treatment. Researchers want to see if a new drug treatment can help people with these types of cancers. Ob...
What is the current status of trial NCT04708470?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 55 participants. The study started on 2021-10-05. Estimated completion is 2026-11-30.
What conditions does trial NCT04708470 study?
This clinical trial studies the following conditions: Cervical Cancer, Colon Cancer, Human Papilloma Virus, Oropharyngeal Cancer, Hpv.
What interventions are being tested in trial NCT04708470?
The interventions under investigation include: Entinostat (DRUG), PDS01ADC (DRUG), Bintrafusp Alfa (DRUG).
Who is sponsoring clinical trial NCT04708470?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04708470 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04708470's enrollment target sits among peer trials
55 94th of 144 higher than 49 of 144 other Cervical Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cervical Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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