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NCT04287868 · ClinicalTrials.gov registry record · Phase 1
Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies
A Phase 1 study of Cervical Cancer and Oropharyngeal Cancer, sponsored by National Cancer Institute (NCI).
- Active
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
- 1
- Study location
NCT04287868: Active Phase 1 study of Cervical Cancer and Oropharyngeal Cancer, sponsored by National Cancer Institute (NCI).
NCT04287868 is a Phase 1 study of Cervical Cancer and Oropharyngeal Cancer that is active but no longer recruiting, run by National Cancer Institute (NCI). The registered enrollment target is 51 participants, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04287868, a Phase 1 study of Cervical Cancer and Oropharyngeal Cancer, is active but no longer recruiting, sponsored by National Cancer Institute (NCI).
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help. Objective: To learn if a mix of immunotherapy drugs can shrink tumors in people with HPV associated cancers. Eligibility: People ages 18 and older with locally advanced or metastatic HPV associated cancer, such as cervical cancers; cyclin-dependent kinase inhibitor 2A (P16+) oropharyngeal cancers; anal cancers; vulvar, vaginal, penile, and squamous cell rectal cancers; or other locally advanced or metastatic solid tumors (e.g., lung, esophagus) that are known HPV+ cancers Design: Participants will be screened with: * medical history * disease confirmation (or tumor biopsy) * physical exam * body scans (computed tomography (CT), magnetic resonance imaging (MRI), and/or nuclear) * blood tests * electrocardiogram (to measure the electrical activity of the heart) * urine tests. Participants will get PDS0101 injected under the skin every 4 weeks for 6 doses. Then they will get it every 3 months for 2 doses. Participants will get M7824 (MSB0011395C) by intravenous infusion every 2 weeks. For this, a needle is inserted into a vein. The drug is given over a 1-hour period. Participants will get NHS-IL12 injected under the skin every 4 weeks. Participants will get the study drugs for up to 1 year. They will visit the NIH every 2 weeks. They will repeat the screening tests during the study. About 28 days after treatment ends, participants will have a follow-up visit or telephone call. Then they will be contacted every 3 months for 1 year, and then every 6 months after that, for the rest of their life. Patients with cervical cancer with prior pelvic radiation and boost brachytherapy will be enrolled in a separate cohort to evaluate safety and preliminary evidence of efficacy...
Primary Outcome
BOR is defined as a complete response or partial response assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete response is disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm. Partial response is at least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum of diameters.
Conditions Studied
Interventions
- BIOLOGICAL M7824
- BIOLOGICAL PDS0101
- BIOLOGICAL NHS-IL12
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2020-06-09 |
| Est. Completion | 2026-07-01 |
| Phase | Phase 1 |
What the registry record for NCT04287868 still lists
NCT04287868 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 51 participants, a relatively small participant target, below the 570-participant average among 144 other Cervical Cancer trials with a reported enrollment target (91% lower).
The record links to 5 conditions, with Cervical Cancer appearing as the primary indexed condition, and to 3 interventions - of which M7824 is the first listed.
NCT04287868 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT04287868 about?
NCT04287868 is a clinical study titled "Combination Immunotherapy in Subjects With Advanced HPV Associated Malignancies". Background: More than 30,000 cases of human papillomavirus (HPV) associated cancers occur annually in the United States. When these cancers spread, they do not respond well to standard treatments and are often incurable. Researchers want to see if a mix of drugs can help. Objective: To learn if a...
What is the current status of trial NCT04287868?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2020-06-09. Estimated completion is 2026-07-01.
What conditions does trial NCT04287868 study?
This clinical trial studies the following conditions: Cervical Cancer, Oropharyngeal Cancer, Anal Cancer, Vulvar, Vaginal, Penile, Rectal Cancer, HPV Cancers.
What interventions are being tested in trial NCT04287868?
The interventions under investigation include: M7824 (BIOLOGICAL), PDS0101 (BIOLOGICAL), NHS-IL12 (BIOLOGICAL).
Who is sponsoring clinical trial NCT04287868?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04287868 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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Where NCT04287868's enrollment target sits among peer trials
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