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This is a multicenter, randomized, double-blind, parallel-controlled phase I clinical study to evaluate the similarity in PK profile, efficacy, safety and immunogenicity of HLX18 and OPDIVO® in patients with resected esophageal or gastroesophageal junction cancer (EC/GEJC), melanoma (MEL), or urothelial carcinoma (UC).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HLX18 | Experimental | Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle, until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first). |
|
| OPDIVO® | Active Comparator | Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle, for a total of 4 cycles (16 weeks). After 4 cycles, all participants in the OPDIVO® group will receive HLX18 480 mg on Day 1 of each 4-week cycle until 12 months after the randomization (nearly 13 cycles) or investigator-assessed disease recurrence, death, initiation of new anti-tumor therapy, unacceptable drug toxicity, withdrawal of informed consent form, or study termination (whichever occurs first). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HLX18 | Drug | Participants will receive HLX18 (480 mg) on Day 1 of each 4-week cycle |
| |
| Measure | Description | Time Frame |
|---|---|---|
| AUC0-28d | From time 0 to 28 days after the 1st dose(4 weeks) | |
| AUCss | From time 0 to 28 days after the 4th dose(16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| maximum serum drug concentration (Cmax) | up to 16 weeks | |
| trough serum drug concentration (Ctrough) | up to 16 weeks | |
| maximum serum drug concentration at steady state (Cmax,ss) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chang Chen | Contact | +86 138 1686 9003 | chenthoracic@163.com |
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| ID | Term |
|---|---|
| D008545 | Melanoma |
| D002295 | Carcinoma, Transitional Cell |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D000077594 | Nivolumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| OPDIVO® |
| Drug |
Participants will receive OPDIVO® (480 mg) on Day 1 of each 4-week cycle |
|
| up to 16 weeks |
| trough serum drug concentration at steady state (Ctrough,ss) | up to 16 weeks |
| Disease-free survival (DFS) | up to 12 months |
| Adverse events (AEs); Serious adverse events (SAEs); Adverse events of special interest (AESIs) (including immune-related adverse events and infusion-related reactions) | From enrollment to the end of 90-day safety follow-up (up to 15 months) |
| Number of participants with abnormal vital signs, abnormal physical examination findings, abnormal Laboratory tests results (hematology, serum chemistry, thyroid function, coagulation function, and myocardial markers) or abnormal 12-lead ECG readings. | From enrollment to the end of 30-day safety follow-up (up to 13 months) |
| Incidence of anti-drug antibody (ADA) and/or neutralizing antibody (NAb) | up to 24 weeks |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |