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

NCT07796126 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 2025-066
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Squamous Cell Carcinoma Head and Neck Cancer (HNSCC)

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  The ORR is calculated as the proportion of participants with complete response (CR) or partial response (PR) per RECIST v1.1 among all treated participants. CR is the disappearance of all lesions; PR is at least a 30% decrease in the sum of diameters of target lesions. The two-sided 95% confidence interval (CI) for ORR will be estimated using Clopper-Pearson's method.

  Up to 1 year after treatment initiation

Secondary Outcomes (4)

• Overall Survival (OS)

  Up to 2 years after treatment initiation

• Progression Free Survival (PFS)

  Up to 1 year after treatment initiation

• Duration of Response (DOR)

  Up to 2 years after treatment initiation

• Impact on Quality of Life (QOL)

  Up to 1 year after treatment initiation

Study Arms (1)

Toripalimab plus Paclitaxel

EXPERIMENTAL

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

Drug: Toripalimab; Drug: Paclitaxel

Interventions

Toripalimab DRUG

Toripalimab 240mg intravenously every three weeks on weeks 1, 4 and 7 of a 17 week cycle.

Also known as: Loqtorzi, toripalimab-tpzi, JS001, TAB001, Tuoyi

Toripalimab plus Paclitaxel

Paclitaxel DRUG

Paclitaxel 80mg/m2 intravenously over weekly for 8 weeks on weeks 8-15 of each cycle times 3 cycles

Toripalimab plus Paclitaxel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must have histologically confirmed HNSCC deemed to be metastatic or incurable by the treating physician. Participants can have incurable disease at presentation or have been treated with definitive curable surgical resection, chemoradiotherapy (CRT), or both, then relapsed with non-curable disease. Participants diagnosed with HNSCC stage IV-C or metastatic/non-resectable, relapsed disease are eligible for this study
• Participant must have measurable disease, defined by RECIST v1.1.
• Participant must be able to understand a written informed consent document and be willing to sign it.
• Participants must be 18 years of age or older.
• Participant must have a life expectancy of at least six months.
• Participant must have an ECOG performance score of 2.
• Participant must have:
• Total bilirubin ≤ 3 times upper limit of normal (ULN)
• Hemoglobin \> 8 g/dL. Transfusion is permitted
• Absolute neutrophil count (ANC) \> 1.0 K/mm3. Granulocyte colony-stimulating factor (G-CSF) is NOT permitted
• Paclitaxel has known embryo- and fetotoxic effects. Therefore, women of childbearing potential must agree to avoid becoming pregnant and male participants should avoid impregnating a female partner and donating sperm starting at initiation of treatment up until at least 30 days after last dose of toripalimab or paclitaxel.

You may not qualify if:

• Participants with known untreated brain metastases will be excluded from this clinical trial. Stable brain metastases will be allowed, and it will be confirmed by stable brain MRI with and without contrast within 8 weeks of signing consent.
• Participants with uncontrolled chronic obstructive pulmonary disease (COPD), heart disease, or autoimmune disease, in the opinion of the treating physician.
• Participants who are taking any other investigational drugs.
• Participants who are taking prednisone or equivalent steroid \>10 mg per day prior to the start of treatment.
• The washout period is at the treating physician's discretion.
• Once participants are on study, they may be treated with steroids and other immunosuppressants per standard of care.
• Participants with a history of allergic reactions attributed to toripalimab, paclitaxel, or medicines containing Kolliphor ELP (Polyoxyl 35 Castor Oil, NF).
• Participants who are pregnant or breastfeeding. If a breastfeeding participant would like to be part of this study, breastfeeding must be discontinued.
• Participants who have end-stage renal failure are eligible for this study unless they have had a kidney transplant.
• Participants that do not agree to be followed according to the study protocol or have cognitive or physical inability to follow the treatment plan.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Interventions

toripalimab; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Ammar Sukari, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ammar Sukari, M.D.

CONTACT

313-576-8709; sukarim@karmanos.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., Medical Oncology, Division Chief

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 31, 2026
• Study Start: September 30, 2026
• Primary Completion (Estimated): May 29, 2028
• Study Completion (Estimated): May 29, 2029
• Last Updated: August 31, 2026

Record last verified: 2026-08

Locations

US (1)