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NCT07195734 · ClinicalTrials.gov registry record · Phase 2

Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer

A Phase 2 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

Recruiting
Registry status
Phase 2
Development phase
180
Enrollment target
18
Study locations

NCT07195734: Recruiting Phase 2 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, sponsored by National Cancer Institute (NCI).

NCT07195734 is a Phase 2 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 180 participants, below the 208-participant average among 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (13% lower). The trial reports 18 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07195734, a Phase 2 study of Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 and Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).

RECRUITING
Registry status
Phase 2
Development phase
180 participants
Enrollment target
18
Study locations

Study Summary

This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients with PD-L1 positive head and neck squamous cell carcinoma that has come back and spread to nearby tissue or lymph nodes after a period of improvement (locally recurrent) or is persistent. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of cancer cells. Paclitaxel is in a class of medications called antimicrotubule agents. It stops cancer cells from growing and dividing and may kill them. Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Salvage surgery is surgery that takes place to remove tumor tissue after a failure of other treatment. High risk patients also receive radiation therapy uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Cisplatin is in a class of medications known as platinum-containing compounds. It works by killing, stopping or slowing the growth of cancer cells. Adding chemotherapy or chemo-immunotherapy to standard salvage surgery may kill more tumor cells than salvage surgery alone in patients with PD-L1 positive locally recurrent or persistent head and neck squamous cell carcinoma.

Primary Outcome

Will be summarized by treatment arm using standard Kaplan-Meier methods, reporting the estimated 2-year EFS rate with corresponding 95% confidence intervals.

Conditions Studied

Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 Locally Recurrent Head and Neck Squamous Cell Carcinoma Stage II Lip and Oral Cavity Cancer AJCC v8 Locally Recurrent Oral Cavity Squamous Cell Carcinoma Stage II Laryngeal Cancer AJCC v8 Locally Recurrent Hypopharyngeal Squamous Cell Carcinoma Locally Recurrent Laryngeal Squamous Cell Carcinoma Locally Recurrent Oropharyngeal Squamous Cell Carcinoma Stage II Oropharyngeal (p16-Negative) Carcinoma AJCC v8

Interventions

  • DRUG Carboplatin
  • PROCEDURE Biospecimen Collection
  • PROCEDURE Computed Tomography
  • DRUG Cisplatin
  • BIOLOGICAL Cemiplimab

Study Locations (18)

Oregon

  • Clackamas Radiation Oncology Center - Clackamas
  • Providence Newberg Medical Center - Newberg
  • Providence Willamette Falls Medical Center - Oregon City
  • Providence Portland Medical Center - Portland
  • Providence Saint Vincent Medical Center - Portland

Kansas

  • University of Kansas Cancer Center - Kansas City
  • University of Kansas Cancer Center-Overland Park - Overland Park
  • University of Kansas Hospital-Westwood Cancer Center - Westwood

Missouri

  • University of Kansas Cancer Center - Briarcliff - Kansas City
  • University of Kansas Cancer Center - North - Kansas City
  • University of Kansas Cancer Center - Lee's Summit - Lee's Summit

Louisiana

  • LSU Health Baton Rouge-North Clinic - Baton Rouge
  • Our Lady of the Lake Physician Group - Baton Rouge

Nebraska

  • Nebraska Cancer Specialists/Oncology Hematology West PC - MECC - Omaha
  • Nebraska Methodist Hospital - Omaha

California

  • Sutter Medical Center Sacramento - Sacramento

Iowa

  • Methodist Jennie Edmundson Hospital - Council Bluffs

Pennsylvania

  • Thomas Jefferson University Hospital - Philadelphia

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2026-10-09
Est. Completion 2033-02-01
Phase Phase 2
National Cancer Institute (NCI)

3,257 total trials

What NCT07195734 shows while recruiting

NCT07195734 is an interventional study that assigns participants to a tested intervention. The registered 180 participants enrollment target is mid-sized for trials with a published cap, below the 208-participant average among 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials with a reported enrollment target (13% lower).

The record links to 10 conditions, with Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 appearing as the primary indexed condition, and to 5 interventions - of which Carboplatin is the first listed.

NCT07195734 lists 18 locations in 8 states (Oregon, Kansas, Missouri).

Frequently Asked Questions

What is clinical trial NCT07195734 about?

NCT07195734 is a clinical study titled "Testing the Addition of Chemotherapy or Chemo-Immunotherapy to the Usual Surgery for Advanced Head and Neck Cancer". This phase II trial tests the addition of chemotherapy, with carboplatin and paclitaxel, or chemo-immunotherapy, with carboplatin, paclitaxel and cemiplimab to standard salvage surgery followed by post operative radiation therapy and cisplatin for high risk patients, for the treatment of patients wi...

What is the current status of trial NCT07195734?

This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 180 participants. The study started on 2026-10-09. Estimated completion is 2033-02-01.

What conditions does trial NCT07195734 study?

This clinical trial studies the following conditions: Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Clinical Stage II HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8, Locally Recurrent Head and Neck Squamous Cell Carcinoma, Stage II Lip and Oral Cavity Cancer AJCC v8, Locally Recurrent Oral Cavity Squamous Cell Carcinoma.

What interventions are being tested in trial NCT07195734?

The interventions under investigation include: Carboplatin (DRUG), Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Cisplatin (DRUG), Cemiplimab (BIOLOGICAL).

Who is sponsoring clinical trial NCT07195734?

This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT07195734 being conducted?

This trial has 18 study locations across California, Iowa, Kansas, Louisiana, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8

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 NCT07195734's enrollment target sits among peer trials

180 5th of 12 higher than 8 of 12 other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Clinical Stage III HPV-Mediated (p16-Positive) Oropharyngeal Carcinoma AJCC v8 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT07195734

Source: ClinicalTrials.gov NCT07195734, the US trial registry maintained by the National Library of Medicine. NCT07195734 (mid enrollment · multi site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.