PDT For Induction Therapy For Head And Neck Cancer

NCT07214987 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 25-494
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Squamous Cell Carcinoma; Head and Neck Cancer Squamous Cell Carcinoma; Head and Neck Cancer

Keywords

Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy).

Secondary Outcomes (6)

• Proportion Grade 3-5 TRAE-free during curative-intent treatment

  Day 1 of Cycle 1 (each cycle is 21 days) through the completion of 7 weeks of definitive chemoRT or 30 days after surgery for patients who undergo surgery and are deemed by the treating team to not require additional post-operative therapy.

• Overall Response Rate (ORR) after PDT induction therapy

  Day 1 of Cycle 1 (each cycle is 21 days) to day 1 of cycle 3.

• Overall Response Rate (ORR) after curative-intent therapy

  Day 1 of Cycle 3 (each cycle is 21 days) to day of 3-month follow-up visit.

• Event-free Survival

  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

  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).

Study Arms (1)

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.

Drug: Toripalimab-tpzi; Drug: Cisplatin; Drug: Docetaxel

Interventions

Toripalimab-tpzi DRUG

Toripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1.

Also known as: JS001, TAB001, CHS-007, LOQTORZI

PDT (cisplatin + docetaxel + toripalimab) induction therapy

Cisplatin DRUG

Cisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent.

PDT (cisplatin + docetaxel + toripalimab) induction therapy

Docetaxel DRUG

Docetaxel is a taxane chemotherapy agent.

PDT (cisplatin + docetaxel + toripalimab) induction therapy

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 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.
• CPS ≥ 1%
• 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.
• 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.

You may not qualify if:

• 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 with the exception of radiation for cutaneous malignancies involving radiation fields that do not overlap with areas of current disease involvement.
• Pre-existing peripheral neuropathy CTCAE grade 2 or higher
• 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.
• Any second malignancy that required antineoplastic therapy in the previous 6 months.
• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Coherus Oncology, Inc.: collaborator

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

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

Interventions

Cisplatin; Docetaxel

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Thomas Roberts, MD, MBA

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Roberts, MD, MBA

CONTACT

617-726-5130; thomas.roberts@mgh.harvard.edu

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: Principle Investigator

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 9, 2025
• Study Start: March 9, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): September 1, 2029
• Last Updated: January 30, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• Access Criteria: Contact the Partners Innovations team at http://www.partners.org/innovation

Locations

US (2)