Phase 3
N=289
The Efficacy and Safety Study of TORIPALIMAB INJECTION Combined With Chemotherapy for Nasophapyngeal Cancer
Recurrent or Metastatic NPC
Bottom Line
View on ClinicalTrials.gov: NCT03581786 ↗Enrolled (actual)
289
Serious AEs
43.6%
Results posted
Apr 2022
Primary outcome: Primary: IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 — 8.2; 21.4 months
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy (Biological); Placebos (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shanghai Junshi Bioscience Co., Ltd.
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY IRC-assessed Progression-Free Survival (PFS) According to RECIST v1.1 |
8.2; 21.4 | — |
| SECONDARY OS |
33.7; NA | — |
| SECONDARY Investigator-assessed ORR According to RECIST v1.1 |
75.5; 82.2 | — |
| SECONDARY Investigator-assessed DoR According to RECIST v1.1 |
6.0; 16.0 | — |
| SECONDARY Investigator-assessed DCR According to RECIST v1.1 |
90.9; 91.1 | — |
| SECONDARY Investigator-assessed PFS According to RECIST v1.1 |
8.1; 17.3 | — |
| SECONDARY Investigator-assessed PFS Rate at 1 Year |
26.2; 61.4 | — |
| SECONDARY OS Rate at 1 Year |
87.1; 90.9 | — |
| SECONDARY IRC-assessed ORR According to RECIST v1.1 |
67.1; 78.8 | — |
| SECONDARY IRC-assessed DoR According to RECIST v1.1 |
6.0; 18.0 | — |
| SECONDARY IRC-assessed DCR According to RECIST v1.1 |
80.4; 88.4 | — |
| SECONDARY Number of Participants Experiencing an Adverse Event(AE) |
143; 146 | — |
| SECONDARY Anti-drug Antibody(ADA) |
0; 10 | — |
| SECONDARY PFS IRC-assessed Per irRECIST |
8.3; 21.6 | — |
| SECONDARY ORR IRC-assessed Per irRECIST |
67.8; 78.8 | — |
| SECONDARY DoR IRC-assessed Per irRECIST |
5.9; 20.1 | — |
| SECONDARY DCR IRC-assessed Per irRECIST |
81.8; 88.4 | — |
| SECONDARY Investigator-assessed PFS Rate at 2 Years |
15.4; 37.0 | — |
| SECONDARY OS Rate at 2 Years |
65.1; 78.0 | — |
| SECONDARY PFS Investigator-assessed Per irRECIST |
8.1; 17.3 | — |
| SECONDARY ORR Investigator-assessed Per irRECIST |
75.5; 82.2 | — |
| SECONDARY DoR Investigator-assessed Per irRECIST |
5.9; 16.0 | — |
| SECONDARY DCR Investigator-assessed Per irRECIST |
90.9; 91.1 | — |
Summary
This is a randomized, placebo-controlled, multi-center, double blinded, Phase III study to determine the efficacy and safety of TORIPALIMAB INJECTIO（JS001） in combination with gemcitabine/cisplatin compared with placebo in combination with gemcitabine/cisplatin as first-line treatment in patients with histological/cytological confirmation of recurrent or metastatic NPC. The primary endpoint is PFS in all patients. Approximately 280 patients who fulfill all of the inclusion criteria and none of the exclusion criteria will be randomized in a 1:1 ratio to one of the two treatment arms. patients will be randomly assigned to the combination of JS001 (Arm A) or placebo (Arm B) with gemcitabine and cisplatin given every 3 weeks (Q3W) in 3-week cycles.
Eligibility Criteria
Inclusion Criteria
- 1. Age ≥ 18 years and ≤75 years.
- 2. Histological/cytological confirmation of NPC.
- 3. Primarily metastatic (stage IVB as defined by the International Union against Cancer and American Joint Committee on Cancer staging system for NPC, eighth edition) or recurrent NPC that is not amenable for local regional treatment or curative treatment.
- 4. At least 1 measurable lesion according to RECIST version 1.1.
- 5. Life expectancy ≥ 3 months
Exclusion Criteria
- 1. History of severe hypersensitivity reactions to other mAbs or any ingredient of JS001.
- 2. Prior therapy targeting PD-1 receptor, or its ligand PD-L1, or cytotoxic T lymphocyte associated protein 4 (CTLA4) receptor.
- 3. Major surgical procedure other than for diagnosis of NPC within 28 days prior to randomization or anticipation of need for a major surgical procedure during the study
- 4. History of hypersensitivity to gemcitabine or cisplatin or to any of the excipients.
- 5. Female patients who are at pregnancy or lactation.
Data sourced from ClinicalTrials.gov (NCT03581786). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.