Toripalimab + Chemotherapy for Nasopharyngeal Cancer
(TRANSPARENT Trial)
Recruiting in Palo Alto (17 mi)
+5 other locations
Age: Any Age
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 4
Recruiting
Sponsor: Coherus Biosciences, Inc.
Must not be taking: Steroids
Disqualifiers: Local therapy, CNS metastases, others
No Placebo Group
Prior Safety Data
Trial Summary
What is the purpose of this trial?This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the drug combination of Toripalimab, Cisplatin, and Gemcitabine for treating nasopharyngeal cancer?
Research shows that combining gemcitabine and cisplatin is effective for treating recurrent or metastatic nasopharyngeal cancer, suggesting that this combination can help control the disease.
12345Is the combination of Toripalimab, Cisplatin, and Gemcitabine safe for treating nasopharyngeal cancer?
Studies have shown that the combination of Gemcitabine and Cisplatin, which are part of the treatment, has been evaluated for safety in nasopharyngeal cancer. While some patients experienced significant side effects, the treatment was generally considered to have acceptable safety levels.
15678What makes the drug Toripalimab combined with chemotherapy unique for nasopharyngeal cancer?
The drug Toripalimab, when combined with standard chemotherapy (Cisplatin and Gemcitabine), offers a unique advantage for treating nasopharyngeal cancer by significantly improving progression-free survival compared to chemotherapy alone, due to its action as a PD-1 inhibitor that helps the immune system attack cancer cells more effectively.
49101112Eligibility Criteria
This trial is for people with nasopharyngeal cancer that has come back or spread, regardless of their HPV status. Participants must have had at least a 6-month gap since their last radiotherapy or chemotherapy and show measurable signs of the disease based on specific criteria.Inclusion Criteria
Key
My cancer is linked to the Epstein-Barr virus.
My cancer can be measured and has grown in previously treated areas.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Chemotherapy-based treatment
Participants receive a combination of toripalimab, cisplatin (or carboplatin), and gemcitabine
6-12 weeks
Maintenance treatment
Participants continue with single-agent toripalimab
Variable
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study tests Toripalimab in combination with chemotherapy drugs Cisplatin and Gemcitabine. Some participants may receive Carboplatin instead. The goal is to see how well these treatments work together against recurrent metastatic nasopharyngeal cancer.
1Treatment groups
Experimental Treatment
Group I: Toripalimab + cisplatin (or carboplatin) + gemcitabineExperimental Treatment4 Interventions
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.
Cisplatin is already approved in European Union, United States, Canada, Japan for the following indications:
🇪🇺 Approved in European Union as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇺🇸 Approved in United States as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇨🇦 Approved in Canada as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
🇯🇵 Approved in Japan as Platinol for:
- Testicular cancer
- Ovarian cancer
- Cervical cancer
- Bladder cancer
- Head and neck cancer
- Esophageal cancer
- Lung cancer
- Mesothelioma
- Brain tumors
- Neuroblastoma
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Emory Winship Cancer InstituteAtlanta, GA
Boston Medical CenterBoston, MA
Princess Margaret Cancer CentreToronto, Canada
University of California, San FranciscoSan Francisco, CA
More Trial Locations
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Who Is Running the Clinical Trial?
Coherus Biosciences, Inc.Lead Sponsor
References
Gemcitabine Combined with Cisplatin Has a Better Effect in the Treatment of Recurrent/Metastatic Advanced Nasopharyngeal Carcinoma. [2022]To explore the efficacy and safety of gemcitabine (GEM) combined with cisplatin (DDP) in the treatment of recurrent/metastatic nasopharyngeal carcinoma (NPC).
[Induction chemotherapy with docetaxel plus cisplatin (TP regimen) followed by concurrent chemoradiotherapy with TP regimen versus cisplatin in treating locally advanced nasopharyngeal carcinoma]. [2019]Clinical trials on docetaxel plus cisplatin (DDP) (TP regimen) in treating nasopharyngeal carcinoma (NPC) are still uncertain due to limited samples. This study was to compare the short-term efficacy and toxicity of induction chemotherapy with TP regimen followed by concurrent chemoradiotherapy with TP regimen versus DDP in treating locally advanced NPC.
Combined chemotherapy with cisplatin, docetaxel and capecitabine for metastatic nasopharyngeal carcinoma: a retrospective analysis. [2018]To evaluate the efficacy and toxicity of the combined chemotherapy with docetaxel, capecitabine and cisplatin (TXP) in the treatment of metastatic nasopharyngeal carcinoma (NPC).
Comparison of five cisplatin-based regimens frequently used as the first-line protocols in metastatic nasopharyngeal carcinoma. [2022]No randomized trial has been reported comparing different chemotherapy regimens on disseminated nasopharyngeal carcinoma (NPC). This study aims to compare five cisplatin-based regimens including cisplatin + 5-fluororacil (PF), paclitaxel + cisplatin (TP), gemcitabine + cisplain (GP), paclitaxel + cisplatin + 5-fluororacil (TPF), and bleomycin + cisplatin + 5-fluororacil (BPF) regimen most frequently used as the first-line protocols for metastatic NPC retrospectively.
Gemcitabine plus cisplatin for patients with recurrent or metastatic nasopharyngeal carcinoma in Taiwan: a multicenter prospective Phase II trial. [2022]This multicenter Phase II trial evaluated the toxicity/efficacy of gemcitabine plus cisplatin as first-line chemotherapy in patients with recurrent/metastatic nasopharyngeal carcinoma.
Metastatic nasopharyngeal carcinoma outcomes in patients on cisplatin with nolatrexed or 5-fluorouracil. [2019]Nasopharyngeal carcinoma (NPC) is one of the most common malignant tumors in southern China. In this study, we compared the clinical efficacy and toxicity of cisplatin with nolatrexed (LP) or 5-fluorouracil (FP) for NPC.
Concurrent weekly carboplatin and radiotherapy for nasopharyngeal carcinoma: report of a joint phase II study. [2019]We report a phase I/II study of weekly concurrent carboplatin and radiotherapy in patients with nasopharyngeal carcinoma (M0 stage). Of 47 patients registered, 45 completed the treatment course. Twenty-six (55%) (95% CI, 41-69%) patients experienced > or =grade 3 acute toxicity (RTOG). Five (11%) (95% CI, 2-20%) patients experienced > or =grade 3 chronic toxicity. This regimen appears to have acceptable toxicity compared to the experimental arm of Phase III Intergroup Study 0099, but progression-free and overall survival are probably inferior. At present, there is no data to suggest that carboplatin can replace cisplatin for concurrent chemoradiation for NPC.
Treatment outcome of docetaxel, capecitabine and cisplatin regimen for patients with refractory and relapsed nasopharyngeal carcinoma who failed previous platinum-based chemotherapy. [2022]Although cisplatin combined with 5-fluorouracil is a common first-line regimen for advanced nasopharyngeal carcinoma (NPC), there are no standard regimens for refractory or relapsed patients. A study of DXD regimen [cisplatin (D), capecitabine (X) and docetaxel (D)] was conducted to evaluate the efficacy and toxicity for patients with refractory or relapsed NPC.
Toripalimab or placebo plus chemotherapy as first-line treatment in advanced nasopharyngeal carcinoma: a multicenter randomized phase 3 trial. [2022]Gemcitabine-cisplatin (GP) chemotherapy is the standard first-line systemic treatment for recurrent or metastatic nasopharyngeal carcinoma (RM-NPC). In this international, double-blind, phase 3 trial (ClinicalTrials.gov identifier: NCT03581786), 289 patients with RM-NPC and no previous chemotherapy for recurrent or metastatic disease were randomized (1/1) to receive either toripalimab, a monoclonal antibody against human programmed death-1 (PD-1), or placebo in combination with GP every 3 weeks for up to six cycles, followed by monotherapy with toripalimab or placebo. The primary endpoint was progression-free survival (PFS) as assessed by a blinded independent review committee according to RECIST v.1.1. At the prespecified interim PFS analysis, a significant improvement in PFS was detected in the toripalimab arm compared to the placebo arm: median PFS of 11.7 versus 8.0 months, hazard ratio (HR) = 0.52 (95% confidence interval (CI): 0.36-0.74), P = 0.0003. An improvement in PFS was observed across key subgroups, including PD-L1 expression. As of 18 February 2021, a 40% reduction in risk of death was observed in the toripalimab arm compared to the placebo arm (HR = 0.603 (95% CI: 0.364-0.997)). The incidence of grade ≥3 adverse events (AEs) (89.0 versus 89.5%), AEs leading to discontinuation of toripalimab/placebo (7.5 versus 4.9%) and fatal AEs (2.7 versus 2.8%) was similar between the two arms; however, immune-related AEs (39.7 versus 18.9%) and grade ≥3 infusion reactions (7.5 versus 0.7%) were more frequent in the toripalimab arm. In conclusion, the addition of toripalimab to GP chemotherapy as a first-line treatment for patients with RM-NPC provided superior PFS compared to GP alone, and with a manageable safety profile.
Toripalimab plus intensity-modulated radiotherapy for recurrent nasopharyngeal carcinoma: an open-label single-arm, phase II trial. [2022]Label="BACKGROUND">Toripalimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1. We aimed to investigate the efficacy and safety of toripalimab in combination with intensity-modulated radiotherapy (IMRT) for recurrent nasopharyngeal carcinoma (rNPC).
Phase I study of TPF neoadjuvant chemotherapy followed by radical radiotherapy in advanced nasopharyngeal carcinoma. [2019]PF regimen is the standard chemotherapy for advanced head and neck cancers including nasopharyngeal cancer. Recently PF has been found to enhance the tumor control by addition of Taxotere. The purpose of this study was to evaluate the dose-limiting toxicity (DLT) and maximum tolerated dose (MTD) of TPF neoadjuvant regimen (taxotere, cisplatin (DDP) and 5-fluorouracil (5-FU)) followed by radical radiotherapy in advanced nasopharyngeal carcinoma (NPC).
Efficacy, Safety, and Correlative Biomarkers of Toripalimab in Previously Treated Recurrent or Metastatic Nasopharyngeal Carcinoma: A Phase II Clinical Trial (POLARIS-02). [2023]As yet, no checkpoint inhibitor has been approved to treat nasopharyngeal carcinoma (NPC). This study was aimed to evaluate the antitumor activity, safety, and biomarkers of toripalimab, a new programmed death-1 (PD-1) inhibitor for recurrent or metastatic NPC (RM-NPC) refractory to standard chemotherapy.