A Phase 4 interventional study of Toripalimab and Cisplatin in Nasopharyngeal Cancer Recurrent, sponsored by Coherus Oncology, Inc.. Recruiting at 13 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-30.
Sponsored by Coherus Oncology, Inc. · Phase 4, Interventional, and Treatment
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Among 18 studies testing cisplatin in Nasopharyngeal Neoplasms — 2 open to participants now, 3 under way, 1 of them phase 3. Cisplatin · Nasopharyngeal Neoplasms.
Among the 18 studies testing cisplatin in Nasopharyngeal Neoplasms, this one is the 5th largest by planned enrollment of the 17 interventional ones that give a count, is the only one that started in 2024, is the only one in phase 4, and was the 18th registered.
226 studies on the registry are indexed under Nasopharyngeal Neoplasms; 42 are open to participants now.
Browse Nasopharyngeal Neoplasms studies →2 of the 18 studies testing cisplatin in Nasopharyngeal Neoplasms are open now, in 3 countries. Recruiting first, the newest first:
National University Hospital, Singapore · Sites in Singapore
Ages 21 mo–99 yrs
By country, each count listing its studies:
Cisplatin: first FDA approval 1978 (PLATINOL-AQ). What it is approved for, and how studies give it, is on its page →
Of the 32 Nasopharyngeal Neoplasms studies recruiting now, 9 (28%) set no upper age limit and 18 (56%) stop at 75 or younger; 3 take children under 18; 2 take healthy volunteers.
This study: 12 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
18 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 5 · Phase 2 13 · Phase 3 2 · Phase 4 1
First in 1997; this study’s year is marked. 1 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 100 is above the median of 60 across 178 interventional studies indexed under Nasopharyngeal Neoplasms.
Median enrollment 51 across the 17 interventional studies. Of the 9 that completed or were terminated, 1 (11%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 18 have an industry lead sponsor. The 10 most frequent:
Coherus Oncology, Inc. is the lead sponsor of 7 studies on the registry; 2 are open to participants now.
Coherus Oncology, Inc. has 1 study filed under Nasopharyngeal Neoplasms — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 18 studies testing cisplatin in Nasopharyngeal Neoplasms, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
The primary objective of this study is to evaluate the efficacy of toripalimab in combination with chemotherapy (cisplatin and gemcitabine), as measured by objective response rate (ORR) assessed by a Blinded Independent Central Review Committee (BICR) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 in first-line recurrent metastatic nasopharyngeal cancer participants (both Epstein-Barr virus (EBV) and non-EBV-associated).
Key Inclusion Criteria:
Histological or cytological confirmation of recurrent/ nasopharyngeal cancer with either EBV or non-EBV-associated cancer. The following subgroups are included:
Key Exclusion Criteria:
Other protocol-defined inclusion and exclusion criteria apply.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Leptomeningeal disease
Cancer that has spread to the leptomeninges, the thin layers covering the brain and spinal cord, and the fluid between them. It is not the same as brain metastases.
Criteria often treat it separately, and many studies leave it out even where treated brain metastases are allowed.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive the triple combination of cisplatin, gemcitabine and toripalimab (Chemotherapy-based treatment phase) followed by single-agent toripalimab (Maintenance treatment phase). The use of cisplatin can be substituted with carboplatin from cycle 2 onwards.
Drug: Toripalimab · Drug: Cisplatin · Drug: Gemcitabine · Drug: Carboplatin
Participants will receive toripalimab via intravenous infusion (IV) on Day 1 every 3 weeks (Q3W) during the Chemotherapy-based treatment phase and Maintenance treatment phase.
Also known as: JS001, TAB-001, CHS-007
Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.
In the event of cisplatin-related nephrotoxicity or at the discretion of the investigator due to cisplatin-related poor tolerability, carboplatin can substitute for cisplatin use from cycle 2 onward. These participants will receive carboplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.
Objective Response Rate (ORR) assessed by a Blinded Independent Central Review (BICR) Committee according to Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1
Time frame: Up to 24 months
Duration of Response (DoR) assessed by BICR according to RECIST v1.1
Time frame: Up to 24 months
ORR assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
DoR assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1
Time frame: Up to 24 months
PFS assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
Overall Survival (OS) defined as time from enrollment to death due to any cause
Time frame: Up to 42 months
Disease Control Rate (DCR) assessed by BICR according to RECIST v1.1
Time frame: Up to 24 months
DCR assessed by the investigator according to RECIST v1.1
Time frame: Up to 24 months
Landmark PFS rates at 1 year and 2 years, derived from Kaplan-Meier (KM) curve
Time frame: 12 months, 24 months
Not enrolling at this site.
Started Nov 2024 (actual). Primary completion is estimated for Dec 2027, 37 months after the start.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Toripalimab · Cisplatin · Gemcitabine
Coherus Oncology, Inc.