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Closed (no longer recruiting)Last updated: 2 February 2024

This phase I trial is testing the safety and activity of two immunotherapies (RO6874281 and Pembrolizumab) in patients with advanced Melanoma that has spread to other parts of the bodyAn Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

Clinical summary

Summary

Eligible participants will be randomised to three parts: a safety run-in (split into cohort 1.1 (for CPI and experienced melanoma participants) and 1.2 (for CPI experienced melanoma participants only) and two expansion parts (part 2 and part 3). Part 2 will commence once all participants in cohort 1.1 have completed observation; part 3 will commence once all participants in cohorts 1.1 and 1.2 have completed observation.

Conditions

This trial is treating patients with melanoma.

Cancer

Skin Cancers Skin

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

An Open-Label, Multicenter, Phase Ib Study To Evaluate Safety And Therapeutic Activity Of RO6874281, An Immunocytokine, Consisting Of Interleukin-2 Variant (IL-2v) Targeting Fibroblast Activation Protein-Α (FAP), In Combination With Pembrolizumab (Anti-PD-1), In Participants With Advanced Or Metastatic Melanoma

Eligibility

Inclusion

  1. Histologically confirmed unresectable stage III or stage IV cutaneous or mucosal melanoma (AJCC v8.0).
  2. Participants need to have known BRAF status.
  3. CPI naïve melanoma population: Participants with unresectable stage III or stage IV cutaneous or mucosal melanoma who have not received prior treatment for advanced disease. BRAF mutation-positive patients are eligible without prior treatment or after failure of BRAF directed inhibitor therapy.
  4. CPI experienced melanoma population: Participants with unresectable stage III or stage IV cutaneous melanoma. Participants must have progressed during or after treatment with anti PD-1 antibody therapy, either as monotherapy or in combination with other agent(s).
  5. Participants should have adequate cardiovascular, hematological, liver, and renal function.
  6. Participants with unilateral pleural effusion are eligible if they fulfill both of the following: NYHA Class 1; Forced expiratory volume 1 (FEV1) >70% and forced vital capacity (FVC) >70% of predicted value; participants with lung metastases should present with DLCO >60% of predicted value.

Exclusion

Medical Conditions

  1. Rapid disease progression or suspected hyperprogression (as determined by the Investigator) or threat to vital organs or critical anatomical sites requiring urgent alternative medical intervention.
  2. Known active CNS metastases and/or carcinomatous meningitis/leptomeningeal disease:

    Participants with previously treated brain metastases may participate.

  3. History of treated asymptomatic CNS metastases.
  4. An active second malignancy (exceptions are non-melanoma skin cancer, cervical carcinoma in situ, or prostate carcinoma that is in remission under androgen deprivation therapy for ≥ 2 years, or participants who have a history of malignancy and have been treated with curative intent and the participant is expected to be cured as per Investigator's assessment).
  5. Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, and known autoimmune diseases or other disease with ongoing fibrosis (such as scleroderma, pulmonary fibrosis. and emphysema).
  6. Episode of significant cardiovascular/cerebrovascular acute disease within 6 months before study treatment administration.
  7. Active or uncontrolled infections, including latent tuberculosis.
  8. Known HIV infection.
  9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
  10. Severe infection within 4 weeks before study treatment administration, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia.
  11. History of chronic liver disease or evidence of hepatic cirrhosis.
  12. Dementia or altered mental status that would prohibit informed consent.
  13. History of autoimmune disease.
  14. Adverse events related to any previous radiotherapy, chemotherapy, targeted therapy, CPI therapy or surgical procedure that have not resolved to Grade =< 1, except alopecia (any grade) and Grade 2 peripheral neuropathy.
  15. History of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis on screening chest computed tomography (CT) scan.
  16. Bilateral pleural effusion.
  17. Severe dyspnea at rest or requiring supplementary oxygen therapy.
  18. Concurrent therapy with any other investigational drug (defined as a treatment for which there is currently no regulatory authority approved indication).
  19. Immunomodulating agents: Last dose with any of the following agents, for example, etanercept, infliximab, tacrolimus, cyclosporine, mycophenolic acid, alefacept, or efalizumab (or similar agents) < 28 days before study treatment administration. Regular immunosuppressive therapy (i.e., for organ transplantation, chronic rheumatologic disease)
  20. Treatment with systemic immunosuppressive medications including, but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF agents within 2 weeks prior to Cycle 1 Day 1.
  21. Radiotherapy within the last 4 weeks before start of study treatment administration, with the exception of limited field palliative radiotherapy.
  22. Administration of a live, attenuated vaccine within 4 weeks before Cycle 1 Day 1.
  23. Major surgery or significant traumatic injury < 28 days before study treatment administration (excluding fine needle biopsies) or anticipation of the need for major surgery during study treatment.
  24. Known hypersensitivity to any of the components of the RO6874281 drug product or pembrolizumab drug product, including but not limited to hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.
  25. No prior cytotoxic therapy for unresectable stage III or stage IV disease is permitted.
  26. Toxicity from prior anti-PD-1 antibody therapy (including adjuvant treatment).

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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