Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nivolumab · 1 trial · 1 indication
pRR was defined as the percentage of participants with pathologic complete response (pCR), pathologic near complete response (pnCR), and pathologic partial response (pPR) as determined by an independent pathologic review. pCR was defined as a complete absence of viable tumor cells, pnCR as \> 0 to ≤ 10% of viable tumor cells, and pPR was defined as \> 10 to ≤ 50% of viable tumor cells in the dissected lymph node. Participants with missing or no pathologic response assessment, including participants who did not proceed to complete lymph node dissection (CLND), were classified as non-responders. pRR was calculated for each arm along with 95% confidence intervals (CIs) using Clopper-Pearson method. The difference in pRR between the experimental arms and the control arm was calculated, along with 95% CIs using the Wald method with continuity correction.
ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) on two consecutive occasions ≥4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1). CR was defined as the disappearance of all target lesions or any pathological lymph nodes (whether target or non-target) having a reduction in the short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of all target lesions, taking as reference the baseline sum of diameters, in the absence of CR. Participants with missing or no response assessments were classified as non-responders. ORR was calculated for each arm, along with 95% CIs using Clopper-Pearson method.
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Nivolumab + Ipilimumab | ACTIVE_COMPARATOR | Cohort 1 participants in the nivolumab plus ipilimumab arm will receive treatment for 2 cycles (6 weeks) on Day 1 of each cycle (cycle length 21 days) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: RO7247669 2100 mg | EXPERIMENTAL | Cohort 1 participants in the RO7247669 arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: + Atezolizumab + Tiragolumab | EXPERIMENTAL | Cohort 1 participants in the atezolizumab plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: RO7247669 2100 mg + Tiragolumab | EXPERIMENTAL | Cohort 1 participants in the RO7247669 plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 2: RO7247669 2100 mg + Tiragolumab | EXPERIMENTAL | Cohort 2 participants in RO7247669 plus tiragolumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status. |
| Cohort 1: RO7247669 600 mg | EXPERIMENTAL | Cohort 1 participants in the RO7247669 arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Cohort 1: RO7247669 600 mg + Tiragolumab | EXPERIMENTAL | Cohort 1 participants in the RO7247669 plus tiragolumab arm will receive treatment for 2 cycles (6 weeks) until surgery, or until unacceptable toxicity or loss of clinical benefit, whichever occurs first. |
| Name | Type | Description |
|---|---|---|
| Nivolumab | DRUG | Nivolumab will be administered at a dose of 3 mg/kg IV on Day 1 of each 21 day cycle. |
| Ipilimumab | DRUG | Ipilimumab will be administered at a dose of 1 mg/kg by IV on Day 1 of each 21 day cycle. |
| RO7247669 2100 mg | DRUG | RO7247669 will be administered at a dose of 2100 mg by IV infusion on Day 1 of each 21 day cycle. |
| Atezolizumab | DRUG | Atezolizumab will be administered at a dose of 1200 mg IV on Day 1 of each 21 day cycle. |
| Tiragolumab | DRUG | Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21 day cycle. |
| RO7247669 600 mg | DRUG | RO7247669 will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle. |
Inclusion Criteria for Cohort 1: * ECOG performance status (PS) of 0 or 1 * Histologically confirmed resectable Stage III melanoma according to AJCC-8 and no history of in-transit metastases within the last 6 months * Fit and planned for CLND * Measurable disease according to RECIST v1.1 * Availabi...
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Nivolumab is an investigational oncology drug being studied for the treatment of melanoma. It is currently in Phase 1 clinical development. The drug is being evaluated in combination with other treatments to assess its efficacy and safety in patients with melanoma.
Nivolumab is a monoclonal antibody, indicated by its -mab suffix. As an antibody-based therapy, it is designed to interact with specific targets involved in cancer. However, the specific molecular target of Nivolumab has not been disclosed in the available information.
Nivolumab is being developed by Roche Holding AG, a biopharmaceutical company traded under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's potential as a treatment for melanoma.
Nivolumab is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is designed to evaluate the drug's safety and efficacy in patients with melanoma.
Nivolumab is being studied in a Phase 1 clinical trial with the identifier NCT05116202. This trial, titled 'A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)', has been completed and enrolled 110 participants across the United States, Australia, France, Italy, and Spain.
Nivolumab is a distinct drug candidate developed by Roche Holding AG. No alternative names for Nivolumab have been reported in the available information. It is being studied specifically for its potential role in treating melanoma.