PDT For Induction Therapy For Head And Neck Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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%
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Toripalimab-tpzi
DrugToripalimab-tpzi is a humanized IgG4 monoclonal antibody specific against human PD-1.
Cisplatin
DrugCisplatin is an injectable chemotherapy agent classified as a platinum-based alkylating agent.
Docetaxel
DrugDocetaxel is a taxane chemotherapy agent.
Treatment groups
26 Participants
are divided into 1 treatment groupGroup A: PDT (cisplatin + docetaxel + toripalimab) induction therapyExperimental treatment 3 interventions
Trial outcomes
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.
Time frame
Day 1 of Cycle 1 (each cycle is 21 days) to Day 10 of Cycle 3 (end of induction therapy).Secondary outcomes
1
Proportion Grade 3-5 TRAE-free during curative-intent treatment
Assessed using NCI Common Terminology for Adverse Event (CTCAE) version 5.0. The rate of participants grade 3+ TRAEs-free during the entire period of curative-intent treatment 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.
Time frame
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.2
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).
Time frame
Day 1 of Cycle 1 (each cycle is 21 days) to day 1 of cycle 3.3
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).
Time frame
Day 1 of Cycle 3 (each cycle is 21 days) to day of 3-month follow-up visit.4
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.
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).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Coherus Oncology, Inc.
Collaborator
Source ClinicalTrials.gov