CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 50 enrolled
Drug / intervention
Nivolumab +2 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03238365
NCT03238365Early Ph 1Completed

Window of Opportunity Trial of Nivolumab and Tadalafil in Patients With Squamous Cell Carcinoma of the Head and Neck

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University·interventional·Posted Aug 3, 2017·Updated Apr 29, 2025

In Brief

A Early Phase 1 clinical trial evaluating Nivolumab, Tadalafil, and 1 other intervention for Lip, Oral Cavity and Pharynx and Larynx. Completed, enrolled 50 participants across 2 sites.

Detailed Summary

This randomized pilot early phase I trial studies how well nivolumab with or without tadalafil work in treating patients with head and neck squamous cell carcinoma that has come back and can be removed by surgery. Monoclonal antibodies, such as nivolumab, may interfere with the ability of tumor cells to grow and spread. Tadalafil may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving nivolumab and tadalafil may work better in treating patients head and neck squamous cell carcinoma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Early Ph 1CompletedFinished
201820192020202120222023202420252026
First PostedAug 3, 2017
Enrollment StartAug 10, 2017
Primary CompletionJul 30, 2019
Study CompletionSep 8, 2022
TodayJul 2, 2026
Enrollment to primary: 2.0 yearsPosted 8.9 years ago

Interventions

Nivolumabbiological

Given IV

Tadalafildrug

Given orally

Therapeutic Conventional Surgeryprocedure

Undergo surgery