Sequential Toripalimab and Paclitaxel in Patients With Head and Neck Squamous Cell Cancer (HNSCC) and Poor Performance Status

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT07796126
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Toripalimab — DRUG
    Toripalimab 240mg intravenously every three weeks on weeks 1, 4 and 7 of a 17 week cycle.
  • Paclitaxel — DRUG
    Paclitaxel 80mg/m2 intravenously over weekly for 8 weeks on weeks 8-15 of each cycle times 3 cycles

Study Details

The goal of this clinical trial is to learn if the drug Toripalimab can prime the tumor to optimize response to Paclitaxel in HNSCC patients with a decrease performance status in a way that make both drugs well tolerated and improve partial or complete response rate over each treatment. The main questions it aims to answer are: * What is the response rate of the cancer to paclitaxel after priming with toripalimab * What is the time to progression if we continue to cycle between toripalimab and paclitaxel * What is the impact on the patient's quality of life and overall survival

Key Dates

First listed
Aug 31, 2026
Start date
Sep 30, 2026
Status verified
Aug 2026
Primary completion
May 29, 2028
Completion
May 29, 2029

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Toripalimab plus Paclitaxel
    Toripalimab 240mg on weeks 1, 4 and 7 in combination with Paclitaxel 80mg/m2 weeks 8-15 with a rest on Weeks 16-17 for 3 cycles. One cycle equals 17 weeks

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 1 year after treatment initiation ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201
Ammar Sukari, M.D.
[email protected]
313-576-8709

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By research site
Karmanos Cancer Institute· Detroit, MI

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