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A clinical trial to look at how well treatment combinations work in people with melanoma (Morpheus-Melanoma)
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
- Melanoma
Trial Status:
Recruiting
This trial runs in
Cities
- Amsterdam
- Barcelona
- Duarte
- Houston
- Leiden
- Lombardia
- Los Angeles
- Madrid
- Marseille
- Napoli
- Pamplona
- Paris
- Perugia
- Santa Monica
- Siena
- Tampa
- Toulouse
- Villejuif
- Wollstonecraft
Trial Identifier:
NCT05116202 BO43328
Trial Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT05116202 , BO43328
Trial Identifier
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Why is the Morpheus-Melanoma clinical trial needed?
Melanoma is a type of skin cancer that can be difficult to treat if it spreads to other organs in the body (advanced melanoma). However new medicines, such as cancer immunotherapies, have shown encouraging results for the treatment of advanced melanoma.
Cancer immunotherapies use the body’s own immune system to destroy cancerous cells. In this trial, several different types of immunotherapy medicines are being tested to see if new combinations of treatments will provide better health outcomes for people with localised or advanced melanoma.
How does the Morpheus-Melanoma clinical trial work?
This clinical trial is recruiting people who have melanoma which is either:
- Localised melanoma that can be removed with surgery (this is known as ‘resectable’) and that has spread to nearby lymph nodes (Group 1)
- OR, advanced melanoma that has spread to other organs, which has become worse during or following a maximum of two previous treatment lines (Group 2).
Depending on how advanced the participants’ melanoma is, they will join one of the two groups. Participants in Group 1 will be randomly split into four groups to receive one of the following treatments: (i) nivolumab plus ipilimumab; (ii) RO7247669; (iii) atezolizumab plus tiragolumab; or (iv) RO7247669 plus tiragolumab. The treatment will be given as an infusion into vein every three weeks or will be stopped if medically unacceptable side effects are experienced. After six weeks (or after stopping treatment), participants in Group 1 will have lymph node(s) surgery on Week 7.
Participants will be seen by the clinical trial doctor on Weeks 1 and 4 (for treatment), Weeks 6, 7, and 10 (for pre-surgery, surgery and post-surgery), and Week 13 (for treatment completion). A follow-up visit (in the clinic) will take place after six months, with further follow-up checks every three months thereafter (which can be completed remotely). These checks are to see how well the participant is responding to the treatment and any side effects they may be having.
All participants in Group 2 will receive RO7247669 plus tiragolumab as an infusion into a vein every three weeks until their cancer worsens or they have medically unacceptable side effects. Participants will be seen by the clinical trial doctor at Weeks 1 and 4 and every three weeks until treatment is stopped, then every three months thereafter. These checks are to see how the participant is responding to the treatment and any side effects they may be having.
Participants’ total time in the clinical trial will vary, depending on which group they are in, how well their cancer responds to treatment and whether they stop treatment because of side effects. This could range from one day to more than one year. After stopping treatment, all participants will be monitored for any side effects for 135 days. Participants are free to stop trial treatment and leave the clinical trial at any time.
What are the main endpoints of the Morpheus-Melanoma clinical trial?
The main clinical trial endpoint for Group 1 (the main results that are measured in the trial to see if the medicine has worked) is to assess tissue samples removed during surgery and after treatment for a lack of all signs of cancer (pathologic response rate).
The other clinical trial endpoints include the number and seriousness of any side effects (unexpected medical problems that occur while on treatment), and how long participants live (overall survival).
The main clinical trial endpoint for Group 2 is to assess how many participants have a reduction in the size of their tumour (objective response rate) that remains at a reduced size when tested again at least four weeks later.
The other clinical trial endpoints include the number and seriousness of any adverse events, overall survival, and how long participants live and without their cancer worsening (progression-free survival).
Who can take part in this clinical trial?
People can take part in this trial if they are at least 18 years old and have been diagnosed with either localised resectable melanoma, or advanced melanoma which has become worse during or following a maximum of two previous lines of treatments.
People may not be able to take part in this trial if they have certain other medical conditions, have previously received certain treatments, are/planning to become pregnant, or are breastfeeding. Participants may not be able to receive treatment related to Group 1 if they have received previous immunotherapy treatment. Participants may not be able to receive treatment related to Group 2 if they have been diagnosed with cancer that has spread to the brain and spinal cord.
What treatment will participants be given in this clinical trial?
This is an open-label trial, which means everyone involved, including the participants and the doctors, know which medicine is being used. Everyone who joins this clinical trial will be enrolled in Group 1 or Group 2, depending on the stage of their disease.
- Group 1: participants with localised melanoma that has spread to lymph nodes will be split randomly into four groups (with an equal chance of receiving one of the four treatment schedules) and will receive either:
- Nivolumab plus ipilimumab, given as an infusion into a vein once every three weeks
- OR RO7247669, given as an infusion into a vein once every three weeks
- OR atezolizumab plus tiragolumab, given as an infusion into a vein once every three weeks
- OR RO7247669 plus tiragolumab, given as an infusion into a vein once every three weeks
- Participants in Group 1 will receive two rounds of treatment over six weeks and will undergo surgery in Week 7
- Group 2: participants with advanced melanoma who have previously received a maximum of two treatment lines will receive:
- RO7247669 plus tiragolumab, given as an infusion once every three weeks.
Are there any risks or benefits in taking part in this clinical trial?
The safety or effectiveness of the experimental treatment or use may not be fully known at the time of the trial. Most trials involve some risks to the participant, although it may not be greater than the risks related to routine medical care or the natural progression of the health condition. Potential participants will be told about any risks and benefits of taking part in the clinical trial, as well as any additional procedures, tests, or assessments they will be asked to undergo. These will all be described in an informed consent document (a document that provides people with the information they need to make a decision to volunteer for a clinical trial). A potential participant should also discuss these with members of the research team and with their usual healthcare provider. Anyone interested in taking part in a clinical trial should know as much as possible about the trial and feel comfortable asking the research team any questions about the trial.
Risks associated with the clinical trial drugs
Participants may have side effects (an unwanted effect of a drug or medical treatment) from the drugs used in this clinical trial. Side effects can be mild to severe and even life-threatening, and can vary from person to person.
Nivolumab, Ipilimumab, Atezolizumab, Tiragolumab, RO7247669
Potential participants will be told about the known side effects of nivolumab, ipilimumab, atezolizumab, tiragolumab, and RO7247669 and where relevant, also potential side effects based on human and laboratory studies or knowledge of similar drugs.
All of these drugs will be given as an intravenous (into a vein) infusion. Participants will be told about any known side effects of intravenous infusion.
Potential benefits associated with the Morpheus-Melanoma clinical trial
Participants' health may or may not improve from participation in the clinical trial, but the information that is collected may help other people who have a similar medical condition in the future.
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For more information about this clinical trial see the For Expert tab on the specific ForPatient page or follow this link to ClinicalTrials.gov: https://clinicaltrials.gov/ct2/show/NCT05116202
Trial-identifier: NCT05116202
Trial Summary
This study will evaluate the efficacy, safety, and pharmacokinetics of treatment combinations in cancer immunotherapy (CIT)-naive participants with resectable Stage III melanoma (Cohort 1) and in participants with Stage IV melanoma (Cohort 2). The study is designed with the flexibility to open new treatment arms as new treatments become available, close existing treatment arms that demonstrate minimal clinical activity or unacceptable toxicity, and modify the participant population.
Hoffmann-La Roche
Sponsor
Phase 1/Phase 2
Phase
NCT05116202 , BO43328
Trial Identifier
Nivolumab, Ipilimumab, RO7247669, Atezolizumab, Tiragolumab
Treatments
Melanoma
Condition
Official Title
A Phase Ib/II, Open-Label, Multicenter, Randomized Umbrella Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
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
- Availability of a representative tumor specimen
- Adequate hematologic and end-organ function
- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening.
Inclusion Criteria for Cohort 2:
- ECOG PS of 0 or 1
- Life expectancy >= 3 months, as determined by the investigator
- Histologically confirmed Stage IV (metastatic) cutaneous melanoma according to AJCC-8
- Disease progression during or following at least one but no more than two lines of treatment for metastatic disease
- Measurable disease according to RECIST v1.1
- Availability of a representative tumor specimen
- Adequate hematologic and end-organ function
- For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- Negative HIV test, negative hepatitis B surface antibody (HBsAb), and negative total hepatitis B core antibody (HBcAb) test, and negative hepatitis C virus (HCV) at screening.
Exclusion Criteria
Exclusion Criteria for Cohort 1:
- Mucosal, uveal and acral lentiginous melanoma
- Distantly metastasized melanoma
- History of in-transit metastases within the last 6 months
- Prior radiotherapy
- Prior immunotherapy, including anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies, and other systemic therapy for melanoma
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
- Prior allogeneic stem cell or solid organ transplantation
- Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
- Active or history of autoimmune disease or immune deficiency
Exclusion Criteria for Cohort 2:
- Mucosal and uveal melanoma
- Treatment with investigational therapy within 28 days prior to initiation of study treatment
- Treatment with systemic immunostimulatory agents within 4 weeks or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment
- Prior allogeneic stem cell or solid organ transplantation
- Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
- Active or history of autoimmune disease or immune deficiency
- Symptomatic, untreated, or progressing CNS metastases
- Active or history of carcinomatous meningitis/leptomeningeal disease
- Uncontrolled tumor-related pain
- Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- Uncontrolled or symptomatic hypercalcemia
For the latest version of this information please go to www.forpatients.roche.com