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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05116202
Registration number
NCT05116202
Ethics application status
Date submitted
22/10/2021
Date registered
10/11/2021
Date last updated
1/05/2024
Titles & IDs
Public title
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Melanoma (Morpheus-Melanoma)
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Scientific 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)
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Secondary ID [1]
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BO43328
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Melanoma
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Condition category
Condition code
Cancer
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Malignant melanoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Nivolumab
Treatment: Drugs - Ipilimumab
Treatment: Drugs - RO7247669 2100 mg
Treatment: Drugs - Atezolizumab
Treatment: Drugs - Tiragolumab
Treatment: Drugs - RO7247669 600 mg
Active Comparator: Cohort 1: Nivolumab + Ipilimumab - 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.
Experimental: Cohort 1: RO7247669 2100 mg - 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.
Experimental: Cohort 1: + Atezolizumab + Tiragolumab - 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.
Experimental: Cohort 1: RO7247669 2100 mg + Tiragolumab - 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.
Experimental: Cohort 2: RO7247669 2100 mg + Tiragolumab - 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.
Experimental: Cohort 1: RO7247669 600 mg - 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.
Experimental: Cohort 1: RO7247669 600 mg + Tiragolumab - 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.
Treatment: Drugs: Nivolumab
Nivolumab will be administered at a dose of 3 mg/kg IV on Day 1 of each 21 day cycle.
Treatment: Drugs: Ipilimumab
Ipilimumab will be administered at a dose of 1 mg/kg by IV on Day 1 of each 21 day cycle.
Treatment: Drugs: RO7247669 2100 mg
RO7247669 will be administered at a dose of 2100 mg by IV infusion on Day 1 of each 21 day cycle.
Treatment: Drugs: Atezolizumab
Atezolizumab will be administered at a dose of 1200 mg IV on Day 1 of each 21 day cycle.
Treatment: Drugs: Tiragolumab
Tiragolumab will be administered at a dose of 600 mg IV on Day 1 of each 21 day cycle.
Treatment: Drugs: RO7247669 600 mg
RO7247669 will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Pathologic Response Rate (pRR) for Cohort 1 as Determined by Independent Pathologic Review
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Assessment method [1]
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pRR is defined as the proportion of participants with pathologic complete response (pCR), pathologic near complete response (pnCR), and pathologic partial response (pPR) at time of surgery, as determined by independent pathologic review.
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Timepoint [1]
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Time of surgery (Week 7)
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Primary outcome [2]
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Objective Response Rate (ORR) for Cohort 2
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Assessment method [2]
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ORR is defined as the proportion 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 RECIST v1.1.
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Timepoint [2]
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Enrollment/randomization up to approximately 5 years
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Secondary outcome [1]
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pRR for Cohort 1 as Determined by Local Pathologic Assessment
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Assessment method [1]
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pRR is defined as the proportion of participants with pCR, pnCR, and pPR at time of surgery, as determined by local pathologic assessment.
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Timepoint [1]
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Time of surgery (Week 7)
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Secondary outcome [2]
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Event-Free Survival (EFS) for Cohort 1
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Assessment method [2]
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EFS is defined as the time from randomization to any of the following events (whichever occurs first): Disease progression that precludes surgery, as assessed by the investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1); local, regional or distant disease recurrence; or death from any cause.
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Timepoint [2]
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Randomization to disease progression that precludes surgery; local, regional or distant disease recurrence; or death from any cause (whichever occurs first) (up to approximately 5 years)
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Secondary outcome [3]
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Relapse-Free Survival (RFS) for Cohort 1
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Assessment method [3]
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RFS is defined as the time from surgery to the first documented recurrence of disease or death from any cause.
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Timepoint [3]
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Surgery to the first documented recurrence of disease or death from any cause (up to approximately 5 years)
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Secondary outcome [4]
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Overall Survival (OS) for Cohort 1
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Assessment method [4]
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OS is defined as the time from randomization to death from any cause.
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Timepoint [4]
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Randomization to death from any cause (up to approximately 5 years)
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Secondary outcome [5]
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Objective Response Rate (ORR) for Cohort 1
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Assessment method [5]
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ORR is defined as the proportion of participants with a complete response (CR) or partial response (PR) as determined by the investigator according to RECIST v1.1, prior to surgery.
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Timepoint [5]
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Prior to surgery (up to Week 6)
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Secondary outcome [6]
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Percentage of Participants With Adverse Events for Cohort 1
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Assessment method [6]
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Timepoint [6]
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Baseline through the end of the study (approximately 5 years)
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Secondary outcome [7]
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Percentage of Participants With Immune-Related Adverse Events for Cohort 1
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Assessment method [7]
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Percentage of participants with immune-related adverse events Grade >= 3 during the first 12 weeks.
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Timepoint [7]
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Baseline to Week 12
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Secondary outcome [8]
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Rate of Delayed Surgery Due to Treatment-Related Adverse Events for Cohort 1
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Assessment method [8]
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Timepoint [8]
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Week 8 to Week 9
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Secondary outcome [9]
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Duration of Delayed Surgery Due to Treatment-Related Adverse Events for Cohort 1
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Assessment method [9]
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Timepoint [9]
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Week 8 to Week 9
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Secondary outcome [10]
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Surgical Complication Rates for Cohort 1
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Assessment method [10]
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Surgical complication rates according to Clavien-Dindo surgical classification after completion lymph node dissection (CLND).
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Timepoint [10]
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Week 7 through Follow-Up (up to approximately 6 months)
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Secondary outcome [11]
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Progression-Free Survival (PFS) for Cohort 2
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Assessment method [11]
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PFS after randomization/enrollment, defined as the time from randomization/enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
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Timepoint [11]
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Randomization/enrollment to the first occurrence of disease progression or death from any cause (whichever occurs first)(up to approximately 5 years)
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Secondary outcome [12]
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Overall Survival (OS) for Cohort 2
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Assessment method [12]
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OS after randomization/enrollment, defined as the time from randomization/enrollment to death from any cause.
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Timepoint [12]
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Randomization/enrollment to death from any cause (up to approximately 5 years)
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Secondary outcome [13]
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Overall Survival (OS) at Specific Timepoints for Cohort 2
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Assessment method [13]
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OS after randomization/enrollment, defined as the time from randomization/enrollment to death from any cause.
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Timepoint [13]
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Randomization/enrollment to death from any cause at specific timepoints (up to approximately 5 years)
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Secondary outcome [14]
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Duration of Response (DOR) for Cohort 2
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Assessment method [14]
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DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.
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Timepoint [14]
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First occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first)(up to approximately 5 years)
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Secondary outcome [15]
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Disease Control for Cohort 2
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Assessment method [15]
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Disease control is defined as stable disease for >= 12 weeks or a CR or PR, as determined by the investigator according to RECIST v1.1.
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Timepoint [15]
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Randomization up to approximately 5 years
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Secondary outcome [16]
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Percentage of Participants With Adverse Events for Cohort 2
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Assessment method [16]
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Timepoint [16]
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Baseline through the end of the study (approximately 5 years)
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Eligibility
Key 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. Patients with a positive HIV test at screening are eligible provided they
are stable on anti-retroviral therapy, have a CD4 count >= 200/µL, and have an
undetectable viral load.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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. Patients with a positive HIV test at screening are eligible provided they
are stable on anti-retroviral therapy, have a CD4 count >= 200/µL, and have an
undetectable viral load.
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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 1/Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
2/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
27/03/2024
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Sample size
Target
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Accrual to date
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Final
110
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Recruitment in Australia
Recruitment state(s)
NSW,WA
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Recruitment hospital [1]
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Melanoma Institute Australia - North Sydney
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Recruitment hospital [2]
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Linear Clinical Research Limited - Nedlands
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Recruitment postcode(s) [1]
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2060 - North Sydney
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Recruitment postcode(s) [2]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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California
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Country [2]
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United States of America
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State/province [2]
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Florida
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United States of America
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State/province [3]
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Texas
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Country [4]
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France
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State/province [4]
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Marseille
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Country [5]
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France
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State/province [5]
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Paris
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Country [6]
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France
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State/province [6]
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Toulouse
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Country [7]
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France
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State/province [7]
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Villejuif
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Country [8]
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Italy
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State/province [8]
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Abruzzo
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Country [9]
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Italy
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State/province [9]
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Campania
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Country [10]
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Italy
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State/province [10]
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Lombardia
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Country [11]
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Italy
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State/province [11]
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Umbria
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Country [12]
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Netherlands
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State/province [12]
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Amsterdam
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Country [13]
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Netherlands
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State/province [13]
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Leiden
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Country [14]
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Spain
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State/province [14]
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Navarra
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Country [15]
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Spain
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State/province [15]
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Barcelona
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Country [16]
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Spain
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State/province [16]
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Madrid
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief 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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05116202
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Clinical Trials
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Address
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Hoffmann-La Roche
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05116202
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