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Alkylating agents

Toripalimab + Chemotherapy for Nasopharyngeal Cancer (TRANSPARENT Trial)

Phase 4

Recruiting

Research Sponsored by Coherus Biosciences, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

EBER/EBV-negative (HPV+/-)

EBER/EBV-positive (HPV+/-)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to study the combination of toripalimab and chemotherapy in patients with nasopharyngeal cancer.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include immune-related reactions due to Toripalimab, kidney issues from Cisplatin, low blood counts from Gemcitabine, and potential nerve damage if Carboplatin is used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My cancer is not linked to Epstein-Barr virus.

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My cancer is linked to the Epstein-Barr virus.

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My nasopharyngeal cancer has returned or spread, and it's been over 6 months since my last treatment.

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My cancer can be measured and has grown in previously treated areas.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Toripalimab

2017

Completed Phase 3

~1260

Cisplatin

2013

Completed Phase 3

~3120