A Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squam… (NCT04856631) | Clinical Trial Compass
CompletedPhase 1/2
A Study of Toripalimab Injection (JS001) + Cetuximab in Treatment of Advanced Head and Neck Squamous Cell Cancer
China88 participantsStarted 2021-04-06
Plain-language summary
This study is a Phase Ib/II, open-label, multicenter clinical trial. Here, the study phase Ib is mainly to evaluate safety of combination regimen of Toripalimab and Cetuximab in treatment of relapsed or metastatic HNSCC failing first-line platinum-based therapy and determine the recommended Phase II dose (RP2D); the study phase II is divided into two cohorts. Cohort A used to evaluate the efficacy and safety of the combination of regimen for relapsed or metastatic HNSCC failing first-line platinum-based regimen containing chemotherapy;cohort B used to evaluate the efficacy and safety of the combination regimen for PD-L1-positive HNSCC that have not received prior systemic therapy for relapsed or metastatic disease.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
.Patients voluntarily participate in this study after full informed consent and sign a written informed consent form;
.Age \>=18 to \<=75 years at time of consenting;
.Advanced, relapsed, or metastatic head and neck squamous cell carcinoma confirmed histologically or cytologically, occurring in the oral cavity, oropharynx, hypopharynx, larynx, or paranasal sinuses, and unsuitable for local therapy such as surgery or radiotherapy.
.Phase Ib and Phase II Cohort A:Previously receiving a first-line platinum-based chemotherapy against relapsed or metastatic disease, and developing progressive disease during or after treatment; or receiving platinum-based chemotherapy as neoadjuvant or adjuvant chemotherapy (or chemoradiotherapy), and developing relapse or metastasis within 6 months after end of treatment.
.Phase II cohort B:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial combined toripalimab, an immunotherapy drug, with cetuximab for advanced head and neck squamous cell cancer — given that it was a Phase 1/2 study, what do we know so far about how safe this combination was, and does the early-phase nature mean there are still unknowns about long-term side effects I should factor in?
2The trial has already completed, so are the results published or available anywhere, and what did the objective response rate actually turn out to be — meaning, how many patients saw their tumors shrink or respond?
3How does combining an immune checkpoint inhibitor like toripalimab with cetuximab compare to the standard treatments available to me right now for advanced head and neck squamous cell cancer?
4Since the Phase 1 part of this trial was specifically measuring the incidence and severity of serious adverse events, were any particular side effects flagged as concerns with this combination that I should be aware of when weighing my options?
5Given that this trial is now completed and no longer enrolling, is there a similar ongoing trial or a way to access either of these drugs through other means that might be worth exploring for my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Objective response rate(ORR)evaluated by RECIST 1.1-Phase2
Timeframe: Up to 2 years
2
Incidence and severity of adverse event (AE) and serious adverse event (SAE)-Phase1
. No previous systemic treatment for relapsed or metastatic disease. Relapse or metastasis more than 6 months after the end of treatment if previously treated with systemic therapy as part of local treatment.
. Qualified tumor tissue samples with positive PD-L1 expression (defined as Combined Positive Score (CPS) ≥ 1) tested by the central laboratory are required.
Exclusion criteria
. Nasopharyngeal cancer or salivary gland cancer confirmed histologically or cytologically, or other non-squamous cell cancer (e.g., adenocarcinoma, sarcoma, or mixed cancer), or metastatic squamous cell cancer with unknown primary site.
. Patients with necrotic lesion, at risk for major hemorrhage as judged by the investigator.
. Previously receiving other immune checkpoint inhibitors/drugs acting on immune checkpoint pathway/other drugs acting on T cell costimulation (e.g.: PD-1/PD-L1 antibody or CTLA-4 antibody);
. Previous treatment of EGFR inhibitor (including radiotherapy sensitization therapy);
. Diagnosed with other malignancies within 5 years prior to study entry, except for basal cell carcinoma of the skin or squamous cell carcinoma, superficial bladder cancer, carcinoma in situ of the cervix or carcinoma in situ of the breast that can be cured by local therapy
. Existing uncontrollable or symptomatic active central nervous system (CNS) metastasis, that may be characterized by clinical symptoms, cerebral edema, spinal cord compression, cancerous meningitis, pia mater disease, and/or progressive growth;
. Major surgery within 28 d prior to the first dose of the investigational therapy (tissue biopsy required for diagnosis, and pieripherally inserted central catheter \[PICC\] or infusion port implantation are permissible).
. Antitumor therapy (including chemotherapy, radiotherapy, immunotherapy, endocrine therapy, targeted therapy, cytokine therapy, or biological therapy, etc.) with 28 d prior to the first dose of the investigational medical product;