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

August 25, 2026 updated by: Ammar Sukari, Barbara Ann Karmanos Cancer Institute

A Phase 2 Pilot Study of the Role of Sequential Immune Checkpoint Inhibitor Toripalimab and Chemotherapy Paclitaxel in Patients With HNSCC and ECOG Performance Score of 2

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Toripalimab treatment will be administered on an outpatient basis. Toripalimab will be given in the clinic on Day 1. Intravenous (IV) infusions will be given every three weeks thereafter for the first seven weeks of the study. Administration follows standard of care.

Paclitaxel treatment will be administered on an outpatient basis as per standard of care once weekly for a total of eight weeks during Weeks 8-15 of each cycle. Premedication and administration follow standard of care. After eight weeks of chemotherapy, the participant finishes the cycle with two weeks of rest (no treatment).

This will be repeated for a total of 51 weeks total of 3 cycles (each cycle is 17 weeks) We will study sequential ICI and CT on HNSCC, and the impact on quality of life in addition to studying the tumor microenvironment. Participants undergo an optional biopsy before and after eight weeks of weekly paclitaxel. To explore the cytotoxic signature, we will calculate the enrichment scores for canonical cytotoxic markers (GZMA, GZMB, GZMK, GNLY, IFNG, PRF1 and NKG7). To estimate the signature of collagen formation, we will calculate enrichment scores using the gene lists from the REACTOME_COLLAGEN_FORMATION pathway (msigdb.v7.5.1.symbols.gmt; https://www.gsea-msigdb.org/gsea/index.jsp). To explore the cell type contexts, we will perform principal component analysis (PCA) and then uniform manifold approximation and projection (UMAP) using the RunPCA and RunUMAP functions based on the cell type proportion inferred by spatial transcriptomics deconvolution (STRIDE). Results will be summarized using descriptive statistics, including mean, median, standard deviation, range, count, and percentage, as appropriate.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
22

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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:

    1. Total bilirubin ≤ 3 times upper limit of normal (ULN)
    2. Hemoglobin > 8 g/dL. Transfusion is permitted
    3. 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Drug: Toripalimab
Toripalimab 240mg intravenously every three weeks on weeks 1, 4 and 7 of a 17 week cycle.
Other Names:
  • JS001
  • Tuoyi
  • TAB001
  • Loqtorzi
  • toripalimab-tpzi
Drug: Paclitaxel
Paclitaxel 80mg/m2 intravenously over weekly for 8 weeks on weeks 8-15 of each cycle times 3 cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to 1 year after treatment initiation
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to 2 years after treatment initiation
The OS is the length of time from the start of treatment that participants are still alive. The distribution of OS will be graphically summarized using a Kaplan-Meier (KM) curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Up to 2 years after treatment initiation
Progression Free Survival (PFS)
Time Frame: Up to 1 year after treatment initiation
PFS is defined as the time duration from treatment start to progression or death from any cause, whichever occurs first. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions. The distribution of PFS will be graphically summarized using a KM curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Up to 1 year after treatment initiation
Duration of Response (DOR)
Time Frame: Up to 2 years after treatment initiation
DOR is the length of time that a tumor continues to respond to treatment without the cancer growing or spreading. The distribution of DOR will be graphically summarized using a KM curve with corresponding median and two-sided 95% CIs computed using KM estimates.
Up to 2 years after treatment initiation
Impact on Quality of Life (QOL)
Time Frame: Up to 1 year after treatment initiation
QOL will be measured using the Functional Assessment of Cancer Therapy for Head & Neck cancer (FACT-H&N). The distribution of QOL will be assessed, and if necessary, a data transformation will be applied to meet normality assumptions. Longitudinal QOL will be summarized using the mean, median, standard deviation (SD), range, and 95% CI across all time points. Minimally important differences (MID) in FACT scores will be determined; for FACT-General the MID is 3 to 7 and for all the subscales the MID is 2 to 3.
Up to 1 year after treatment initiation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Barbara Ann Karmanos Cancer Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ammar Sukari, M.D., Barbara Ann Karmanos Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 29, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 29, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 31, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 31, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-066 (Other Identifier: Turkish Medicines and Medical Devices Agency Clinical Trial Authorization Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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