Squamous Cell CarcinomaPhase 2NCT07214987
PDT For Induction Therapy For Head And Neck Cancer
A Phase 2 study testing Toripalimab-tpzi, Cisplatin and Docetaxel in people with Squamous Cell Carcinoma and Head and Neck Cancer Squamous Cell Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.
Trial summary
This research study is being done to assess the safety and tolerability of toripalimab in combination with cisplatin and docetaxel (PDT) induction therapy for patients with CPS-positive locally advanced head and neck squamous cell carcinoma (HNSCC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma, Head and Neck Cancer Squamous Cell Carcinoma, Head and Neck Cancer
- What is being tested?
- Toripalimab-tpzi, Cisplatin and Docetaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Mar 2026to 1 Sep 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have a new diagnosis of histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, sinonasal cavities or unknown primary HNSCC.
- Participants with HPV-independent SCC or HNSCC or other head and neck subsites must have stage III or non-metastatic stage IV at the time of diagnosis. Participants with HPV-associated oropharynx SCC must have stage II or stage III disease.
- Participants must be determined by the investigator to be candidates for induction systemic therapy due to reasons such as the extent of primary tumor at the time of diagnosis, rate of progression, symptom burden or potential benefit of cytoreduction prior to definitive local therapy.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of toripalimab in combination with cisplatin and docetaxel in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status ≤ 1
- Life expectancy of greater than 12 weeks.
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- Participants must meet the following organ and marrow function as defined below:
- Hemoglobin ≥8.0 g/dL absolute neutrophil count ≥1500/mcL platelets ≥100,000/mcL total bilirubin ≤ 2 institutional upper limit of normal (ULN) AST(SGOT)/ALT(SGPT) ≤ 2 × institutional ULN creatinine ≤ 2 x institutional ULN OR glomerular filtration rate (GFR) ≥ 45 mL/min/1.73 m2
- Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
- Because immunotherapy agents as well as cisplatin and docetaxel are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of toripalimab administration.
- Ability to understand and the willingness to sign a written informed consent document.
Who cannot join
- Diagnosis of EBV-associated nasopharynx squamous cell carcinoma
- Strong clinical suspicion or histologic confirmation of cutaneous squamous cell carcinoma
- Histology other than squamous cell carcinoma.
- Proven distant metastases (below the clavicle) by clinical or radiographic measures.
- Prior radiotherapy to the head and/or neck that excludes the patient from receiving curative-intent radiation to involved areas.
- Pre-existing peripheral neuropathy CTCAE grade 2 or higher
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- Participants who are receiving any other investigational agents for this condition.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to toripalimab, cisplatin or docetaxel.
- An autoimmune condition requiring treatment with systemic corticosteroids within the past 30 days. Long-term steroid replacement for patients with adrenal insufficiency is allowed.
- Presence of a second malignancy that is considered active by the investigator. A second malignancy should be considered active if any one of the following are present: Administration of antineoplastic therapy for the second malignancy in the previous 6 months; Clinically significant radiographic changes in the prior 6 months that are attributed to the second malignancy; Concern by the investigator that the second malignancy may require antineoplastic treatment during the patient's treatment for their head and neck cancer or in the next 6 months, whichever timeframe is expected to be longer
- Participants receiving any medications or substances that are moderate or strong inhibitors or inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly changing, it is important to regularly consult a frequently updated medical reference. As part of the enrollment/informed consent procedures, the participant will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the participant is considering a new over-the-counter medicine or herbal product.
- Pregnant women are excluded from this study because toripalimab, cisplatin and docetaxel have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with toripalimab, cisplatin and docetaxel, breastfeeding should be discontinued if the mother is treated with toripalimab. These potential risks may also apply to other agents used in this study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Thomas Roberts, MD, MBA, 617-726-5130, thomas.roberts@mgh.harvard.edu
Thomas Roberts, MD, MBA
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Michael J Dennis, MD, 617-632-3090, michael_dennis@dfci.harvard.edu
Michael J Dennis, MD
About this study
Official title: A Phase 2 Study of Toripalimab in Combination With Cisplatin and Docetaxel (PDT) for Induction Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
This research study is being done to assess the safety and tolerability of toripalimab in combination with cisplatin and docetaxel (PDT) induction therapy for patients with CPS-positive locally advanced head and neck squamous cell carcinoma (HNSCC).
Read the detailed description
This is a single arm phase II study to assess treatment-related adverse events (TRAEs) and efficacy of PDT. The study employs a Simon two-stage design. After 12 evaluable participants start treatment with at least 2 participants experiencing no grade 3 or higher TRAEs during induction therapy, then enrollment will continue to the target number of participants of 26. Participants will receive treatment for three cycles or until disease progression, they experience unacceptable side effects, their condition changes rendering them unacceptable for further treatment, or they withdraw from the study. Participants will be followed for two years from registration. Coherus Biosciences, Inc. is supporting this research study by providing the study drug, toripalimab, and funding for research activities. The U.S. FDA has not approved toripalimab for CPS-positive locally advanced HNSCC but has approved it for other forms of head and neck cancer. Toripalimab is a lab-made antibody that works by allowed the immune system to attack cancer cells more effectively. Toripalimab is currently sold as LOQTORZI and is used with cisplatin and gemcitabine to treat nasopharyngeal carcinoma. The U.S. FDA has approved cisplatin and docetaxel as a treatment option for multiple types of cancers, including head and neck small cell carcinoma. Cisplatin is a chemotherapy agent that works by binding to cancer cells and initiating cell death. Docetaxel is a chemotherapy agent made from a compound found in the European yew tree. Docetaxel works by stabilizing tiny structures within cancer cells, prevent cell growth and, ultimately leading to cell death. The combination of toripalimab with cisplatin and docetaxel for induction therapy is investigational.
- Conditions
- Squamous Cell Carcinoma, Head and Neck Cancer Squamous Cell Carcinoma, Head and Neck Cancer
- Keywords
- Head and Neck Squamous Cell Carcinoma
- Medical subject headings
- Carcinoma, Squamous Cell, Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toripalimab-tpziDrug
Also called JS001, TAB001, CHS-007, LOQTORZI
Toripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1.
CisplatinDrug
Cisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent.
DocetaxelDrug
Docetaxel is a taxane chemotherapy agent.
| Study group | Role | What they receive |
|---|---|---|
| PDT (cisplatin + docetaxel + toripalimab) induction therapy | Experimental | Toripalimab, cisplatin, and docetaxel will be given once every 21 days, +/- a window of 5 days, by intravenous infusion. On day 1 of each cycle, the pre-determined dose of toripalimab will be administered over about 60 minutes. The pre-determined dose of docetaxel will then be administered over about 1 hour. After docetaxel, the pre-determined dose of cisplatin will be administered over about 1-3 hours. This will continue for up to 3 cycles. Participants may be pre-medicated with drugs to reduce the chance of having a sensitivity reaction to the study treatment. The decision to pursue definitive chemoradiotherapy should be made by a multidisciplinary team specializing in treating head and neck cancers. For patients receiving chemoradiotherapy, the recommended concurrent chemotherapy regimen used with radiotherapy is weekly cisplatin. Receives: Drug: Toripalimab-tpzi; Drug: Cisplatin; Drug: Docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion Grade 3-5 TRAE-free during induction therapy
Assessed using NCI Common Terminology for Adverse Event (CTCAE) version 5.0. The rate of patients with grade 3+ TRAEs-free during induction therapy will be summarized as a proportion with a corresponding exact 95% confidence interval (CI) (if the trial closes to accrual after the first stage), or a proportion with a corresponding 95% two-stage confidence interval (CI) if the trial closes to accrual after the second stage.
Measured: Day 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy).
Secondary outcomes (5)
Overall Response Rate (ORR) after PDT induction therapy
The overall response rate (ORR) will be summarized as a proportion with a corresponding exact 95% two-stage confidence interval (CI).
Measured: Day 1 of Cycle 1 (each cycle is 21 days) to day 1 of cycle 3.
Overall Response Rate (ORR) after curative-intent therapy
The overall response rate (ORR) will be summarized as a proportion with a corresponding exact 95% two-stage confidence interval (CI).
Measured: Day 1 of Cycle 3 (each cycle is 21 days) to day of 3-month follow-up visit.
Event-free Survival
The Kaplan-Meier method will be used to estimate time-to-event endpoints with corresponding 95% confidence intervals (CIs) for the median or time-specific event time.
Measured: Day 1 of Cycle 1 (each cycle is 21 days) to date of death or for up to 2 years from study registration (whichever comes first).
Overall Survival
Overall survival is the time from start of treatment to death due to any cause. The Kaplan-Meier method will be used to estimate time-to-event endpoints with corresponding 95% confidence intervals (CIs) for the median or time-specific event time.
Measured: Day 1 of Cycle 1 (each cycle is 21 days) to date of death or for up to 2 years from study registration (whichever comes first).
Participant's Quality of Life
Patient-Reported Outcomes Measurement Information System Global 10 (PROMIS-10) Physical Health T-score and Global Mental Health T-score will be summarized descriptively via PROMIS-10 scores. The minimum score is 16 and the maximum is 68. A higher score is associated with better outcomes.
Measured: Baseline until to 2 years from study registration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start9 Mar 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion1 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Coherus Oncology, Inc.
- Responsible party
- Principal investigator, Thomas J. Roberts, MD, Massachusetts General Hospital
- Investigators
- Thomas Roberts, MD, MBA, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07214987
- Sponsor's protocol ID
- 25-494
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Thomas Roberts, MD, MBA at 617-726-5130. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study of Toripalimab in Combination With Cisplatin and Docetaxel (PDT) for Induction Therapy in Locally Advanced Head and Neck Squamous Cell Carcinoma
- ClinicalTrials.gov ID
- NCT07214987
- Acronym / sponsor ID
- 25-494
- Conditions
- Squamous Cell Carcinoma, Head and Neck Cancer Squamous Cell Carcinoma, Head and Neck Cancer
- Keywords
- Head and Neck Squamous Cell Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Coherus Oncology, Inc.
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 1 Sep 2029 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study is being done to assess the safety and tolerability of toripalimab in combination with cisplatin and docetaxel (PDT) induction therapy for patients with CPS-positive locally advanced head and neck squamous cell carcinoma (HNSCC).
Detailed description
This is a single arm phase II study to assess treatment-related adverse events (TRAEs) and efficacy of PDT. The study employs a Simon two-stage design. After 12 evaluable participants start treatment with at least 2 participants experiencing no grade 3 or higher TRAEs during induction therapy, then enrollment will continue to the target number of participants of 26. Participants will receive treatment for three cycles or until disease progression, they experience unacceptable side effects, their condition changes rendering them unacceptable for further treatment, or they withdraw from the study. Participants will be followed for two years from registration. Coherus Biosciences, Inc. is supporting this research study by providing the study drug, toripalimab, and funding for research activities. The U.S. FDA has not approved toripalimab for CPS-positive locally advanced HNSCC but has approved it for other forms of head and neck cancer. Toripalimab is a lab-made antibody that works by allowed the immune system to attack cancer cells more effectively. Toripalimab is currently sold as LOQTORZI and is used with cisplatin and gemcitabine to treat nasopharyngeal carcinoma. The U.S. FDA has approved cisplatin and docetaxel as a treatment option for multiple types of cancers, including head and neck small cell carcinoma. Cisplatin is a chemotherapy agent that works by binding to cancer cells and initiating cell death. Docetaxel is a chemotherapy agent made from a compound found in the European yew tree. Docetaxel works by stabilizing tiny structures within cancer cells, prevent cell growth and, ultimately leading to cell death. The combination of toripalimab with cisplatin and docetaxel for induction therapy is investigational.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PDT (cisplatin + docetaxel + toripalimab) induction therapy | Experimental | Drug: Toripalimab-tpzi, Drug: Cisplatin, Drug: DocetaxelToripalimab, cisplatin, and docetaxel will be given once every 21 days, +/- a window of 5 days, by intravenous infusion. On day 1 of each cycle, the pre-determined dose of toripalimab will be administered over about 60 minutes. The pre-determined dose of docetaxel will then be administered over about 1 hour. After docetaxel, the pre-determined dose of cisplatin will be administered over about 1-3 hours. This will continue for up to 3 cycles. Participants may be pre-medicated with drugs to reduce the chance of having a sensitivity reaction to the study treatment. The decision to pursue definitive chemoradiotherapy should be made by a multidisciplinary team specializing in treating head and neck cancers. For patients receiving chemoradiotherapy, the recommended concurrent chemotherapy regimen used with radiotherapy is weekly cisplatin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Participants must have a new diagnosis of histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, larynx, nasopharynx, sinonasal cavities or unknown primary HNSCC.
- Participants with HPV-independent SCC or HNSCC or other head and neck subsites must have stage III or non-metastatic stage IV at the time of diagnosis. Participants with HPV-associated oropharynx SCC must have stage II or stage III disease.
- Participants must be determined by the investigator to be candidates for induction systemic therapy due to reasons such as the extent of primary tumor at the time of diagnosis, rate of progression, symptom burden or potential benefit of cytoreduction prior to definitive local therapy.
- Age ≥18 years. Because no dosing or adverse event data are currently available on the use of toripalimab in combination with cisplatin and docetaxel in participants <18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.
- ECOG performance status ≤ 1
Key exclusion criteria (12 listed)
- Diagnosis of EBV-associated nasopharynx squamous cell carcinoma
- Strong clinical suspicion or histologic confirmation of cutaneous squamous cell carcinoma
- Histology other than squamous cell carcinoma.
- Proven distant metastases (below the clavicle) by clinical or radiographic measures.
- Prior radiotherapy to the head and/or neck that excludes the patient from receiving curative-intent radiation to involved areas.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toripalimab-tpziAlso: JS001, TAB001, CHS-007, LOQTORZIToripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1. | Drug | PDT (cisplatin + docetaxel + toripalimab) induction therapy |
| CisplatinCisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent. | Drug | PDT (cisplatin + docetaxel + toripalimab) induction therapy |
| DocetaxelDocetaxel is a taxane chemotherapy agent. | Drug | PDT (cisplatin + docetaxel + toripalimab) induction therapy |
Primary outcome
Proportion Grade 3-5 TRAE-free during induction therapy
Time frame: Day 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy).
Assessed using NCI Common Terminology for Adverse Event (CTCAE) version 5.0. The rate of patients with grade 3+ TRAEs-free during induction therapy will be summarized as a proportion with a corresponding exact 95% confidence interval (CI) (if the trial closes to accrual after the first stage), or a proportion with a corresponding 95% two-stage confidence interval (CI) if the trial closes to accrual after the second stage.
5 secondary outcomes
Overall Response Rate (ORR) after PDT induction therapy
Time frame: Day 1 of Cycle 1 (each cycle is 21 days) to day 1 of cycle 3.
Overall Response Rate (ORR) after curative-intent therapy
Time frame: Day 1 of Cycle 3 (each cycle is 21 days) to day of 3-month follow-up visit.
Event-free Survival
Time frame: Day 1 of Cycle 1 (each cycle is 21 days) to date of death or for up to 2 years from study registration (whichever comes first).
Overall Survival
Time frame: Day 1 of Cycle 1 (each cycle is 21 days) to date of death or for up to 2 years from study registration (whichever comes first).
Participant's Quality of Life
Time frame: Baseline until to 2 years from study registration.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: Yes. The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Thomas Roberts, MD, MBA at 617-726-5130. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Thomas Roberts, MD, MBA principal investigator
Massachusetts General Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Toripalimab-tpzi, Cisplatin and Docetaxel in people with Squamous Cell Carcinoma and Head and Neck Cancer Squamous Cell Carcinoma, run by Massachusetts General Hospital at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Roberts, MD, MBA (617-726-5130, thomas.roberts@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion Grade 3-5 TRAE-free during induction therapy (time frame: Day 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.