Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial (NCT03815058) involved people with a type of skin cancer called melanoma. It tested two approaches: one group received a drug called pembrolizumab on its own, and another received pembrolizumab combined with an experimental drug called RO7198457. A small initial safety group of 6 people was enrolled first, followed by a randomised stage where 41 people were assigned to pembrolizumab alone and 84 to the combination. A further 10 people later crossed over to receive the combination treatment after initially being in the pembrolizumab-only group. The reported data shows that the main thing being measured was how long participants went without their cancer growing or spreading — called progression-free survival. For the pembrolizumab-only group, the reported median time was 7.9 months, and for the combination group it was 8.3 months. For the proportion of participants whose tumours shrank by a meaningful amount (called objective response rate), the reported figures were approximately 49% in the pembrolizumab-only group and 42% in the combination group. For overall survival (time from enrolment to death from any cause), a median figure was not reached for the pembrolizumab-only group, meaning not enough events had occurred to calculate it, while the combination group had a reported median of 62.2 months. How long those responses lasted (duration of response) was not reported as a calculable number for either group. Among the 10 people who crossed over to the combination, 40% were reported to have had a meaningful reduction in tumour size. Quality-of-life scores were also measured using a standard questionnaire, with baseline scores of around 65 (out of 100) for the pembrolizumab-only group and 73 for the combination group, and the reported changes from those baselines over time were relatively small in both directions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Melanoma Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been diagnosed with melanoma (a type of skin cancer) that has spread to other parts of the body, or cannot be surgically removed, and it started in the skin, hands/feet, or mucous membranes (such as the mouth or nose lining)
- Your general health and ability to carry out daily activities is reasonably good, as measured by a standard medical scale (confirm with trial site)
- Your doctor expects you to live for at least 12 weeks
- Your blood counts and organ functions (such as liver and kidneys) are within acceptable ranges
- You have not previously received systemic (whole-body) treatment for advanced melanoma, though some exceptions may apply (confirm with trial site)
- A sample of your tumour tissue is available for testing
- Your cancer can be measured on a scan using standard medical criteria
Who may not be able to join:
- Your melanoma started in the eye (ocular or uveal melanoma)
- You have received anti-cancer treatment previously, with some possible exceptions (confirm with trial site)
- You have cancer that has spread to the brain or spinal cord and is causing symptoms, has not been treated, or is getting worse
- You have previously had your spleen removed
- You have a history of an autoimmune disease (a condition where your immune system attacks your own body)
- You have previously had a bone marrow transplant from a donor or an organ transplant
- You have tested positive for HIV
- You currently have active hepatitis B, hepatitis C, or tuberculosis
- You have a serious heart or blood vessel condition
- You have a significant known liver disease
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Clinical Trials, Hoffmann-La Roche
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
5 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Progression-free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v.1.1) After Randomization
Can't join this trial?
Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.