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A Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Participants With Recurrent Metastatic Nasopharyngeal Cancer

ConditionNasopharyngeal Cancer Recurrent
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age12+
SponsorCoherus Oncology, Inc.

About this trial

This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

EBER/EBV-negative (HPV+/-)

EBER/EBV-positive (HPV+/-)

Recurrent/metastatic (stage IV-B as defined by the International Union against Cancer [UICC] and American Joint Committee on Cancer [AJCC] staging system for nasopharyngeal cancer [NPC], eighth edition) or recurrent NPC after curative treatment. For recurrent NPC, more than 6 months between the last dose of radiotherapy or chemotherapy and the date of recurrence.

Measurable disease based on RECIST v 1.1 as determined by the site. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

Disqualifiers

Disease that is suitable for local therapy administered with curative intent.

Prior systemic therapy administered in the recurrent or metastatic setting. Participants who develop disease recurrence within 6 months from curative intent chemoradiation will be excluded.

Rapidly progressing disease (e.g., tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator.

Active or untreated central nervous system (CNS) metastases (e.g., brain or leptomeningeal), as determined on computerized tomography (CT) or magnetic resonance imaging (MRI) evaluation during screening and prior radiographic assessments. Participants who have prior therapies for brain or leptomeningeal metastasis and have been stabilized ≥ 1 month and have discontinued systemic steroid therapy (>10 mg/day prednisone or equivalent) ≥ 1 month prior to enrollment are eligible.

Trial design

Design model

Single group

Treatments tested in this trial

  • Toripalimab

    Drug

    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.

  • Cisplatin

    Drug

    Participants will receive cisplatin via IV on Day 1 Q3W during the Chemotherapy-based treatment phase.

  • Gemcitabine

    Drug

    Participants will receive gemcitabine via IV on Day 1 and Day 8 Q3W during the Chemotherapy-based treatment phase.

  • Carboplatin

    Drug

    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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Toripalimab + cisplatin (or carboplatin) + gemcitabineExperimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

Duration of Response (DoR) assessed by BICR according to RECIST v1.1

Time frame
Up to 24 months
2

ORR assessed by the investigator according to RECIST v1.1

Time frame
Up to 24 months
3

DoR assessed by the investigator according to RECIST v1.1

Time frame
Up to 24 months
4

Progression-free Survival (PFS) assessed by BICR according to RECIST v1.1

Time frame
Up to 24 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Coherus Oncology, Inc.

Lead sponsor

Source ClinicalTrials.gov
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