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Checkpoint Inhibitor

Immunotherapy Combinations for Melanoma

Phase 1 & 2
Waitlist Available
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For Cohort 2: ECOG PS of 0 or 1
For Cohort 1: Histologically confirmed resectable Stage III melanoma according to AJCC-8 and no history of in-transit metastases within the last 6 months
Must not have
For Cohort 2: Known immunodeficiency or conditions requiring treatment with systemic immunosuppressive medication, or anticipation of need for systemic immunosuppressant medication during study treatment
For Cohort 2: Prior allogeneic stem cell or solid organ transplantation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing new treatments to help the immune system fight cancer in patients with advanced melanoma. It includes patients who have not yet received treatment for their melanoma. The goal is to find effective and safe options for these patients.

Who is the study for?
This trial is for adults with Stage III melanoma eligible for surgery or those with Stage IV melanoma who've had limited treatment. Participants must have good organ function, no HIV/Hepatitis B/C unless controlled, and a performance status showing they can handle daily activities. Exclusions include certain types of melanoma, prior immunotherapy or stem cell transplants, active autoimmune diseases, and uncontrolled symptoms related to cancer.
What is being tested?
The study tests combinations of cancer immunotherapies like Nivolumab, Ipilimumab, RO7247669 (two doses), Atezolizumab, and Tiragolumab in patients new to these treatments. It's flexible; new arms may open/close based on results or safety concerns. The goal is to assess how well the treatments work (efficacy), their safety profile, and how the body processes them.
What are the potential side effects?
Possible side effects from the tested drugs include immune-related reactions that could affect organs like the liver or intestines, skin issues such as rashes or itching, fatigue, hormonal gland problems which might require hormone therapy replacement and infusion-related reactions during drug administration.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am fully active or restricted in physically strenuous activity but can do light work.
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I have Stage III melanoma that can be surgically removed and no recent spread to nearby skin.
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I am fully active or restricted in physically strenuous activity but can do light work.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have an immune system disorder or need medication that weakens my immune system.
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I have had a previous transplant of stem cells or an organ.
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I have had cancer spread to areas between the primary tumor and nearby lymph nodes in the last 6 months.
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I haven't taken any immune-boosting drugs within the last 4 weeks or 5 half-lives before starting the study.
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I need frequent procedures to remove fluid from my chest, heart area, or abdomen.
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I have or had an autoimmune disease or immune deficiency.
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My melanoma has spread to distant parts of my body.
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I have had radiotherapy before.
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I have previously received immunotherapy or other treatments for melanoma.
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I have an immune system disorder or need medication that weakens my immune system.
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I haven't taken any experimental drugs in the last 28 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to approximately 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and randomization up to approximately 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Objective Response Rate (ORR) for Cohort 2
Pathologic Response Rate (pRR) for Cohort 1 as Determined by Independent Pathologic Review
Secondary study objectives
Disease Control for Cohort 2
Duration of Response (DOR) for Cohort 2
Event-Free Survival (EFS) for Cohort 1
+9 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
36%
Fatigue
35%
Alopecia
24%
Diarrhoea
23%
Nausea
23%
Decreased appetite
22%
Anaemia
20%
Asthenia
19%
Cough
19%
Dyspnoea
16%
Myalgia
15%
Neutropenia
14%
Constipation
14%
Oedema peripheral
12%
Pyrexia
11%
Stomatitis
11%
Vomiting
11%
Neuropathy peripheral
10%
Arthralgia
9%
Neutrophil count decreased
9%
Rash
8%
Headache
8%
Dysgeusia
8%
Paraesthesia
7%
Pain in extremity
7%
Mucosal inflammation
7%
Back pain
7%
Peripheral sensory neuropathy
7%
Insomnia
6%
Febrile neutropenia
6%
Pneumonia
6%
Lacrimation increased
6%
Abdominal pain
6%
Dry skin
6%
Dizziness
5%
Malaise
5%
Urinary tract infection
5%
Weight decreased
5%
Haemoptysis
5%
Nail disorder
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
4%
Productive cough
3%
Upper respiratory tract infection
3%
Pruritus
2%
Influenza like illness
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
1%
Syncope
1%
Dehydration
1%
Atrial fibrillation
1%
Lower respiratory tract infection
1%
Lung infection
1%
Respiratory tract infection
1%
Acute kidney injury
1%
Chronic obstructive pulmonary disease
1%
Pleural effusion
1%
Depression
1%
Musculoskeletal chest pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

7Treatment groups
Experimental Treatment
Active Control
Group I: Cohort 2: RO7247669 2100 mg + TiragolumabExperimental Treatment2 Interventions
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.
Group II: Cohort 1: RO7247669 600 mg + TiragolumabExperimental Treatment2 Interventions
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.
Group III: Cohort 1: RO7247669 600 mgExperimental Treatment1 Intervention
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.
Group IV: Cohort 1: RO7247669 2100 mg + TiragolumabExperimental Treatment2 Interventions
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.
Group V: Cohort 1: RO7247669 2100 mgExperimental Treatment1 Intervention
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.
Group VI: Cohort 1: + Atezolizumab + TiragolumabExperimental Treatment2 Interventions
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.
Group VII: Cohort 1: Nivolumab + IpilimumabActive Control2 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RO7247669 2100 mg
2022
Completed Phase 2
~110
Atezolizumab
2016
Completed Phase 3
~5860
Tiragolumab
2019
Completed Phase 3
~1810
RO7247669 600 mg
2022
Completed Phase 2
~110

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for melanoma, particularly advanced stages, involve immune checkpoint inhibitors such as PD-1 inhibitors (nivolumab, pembrolizumab) and CTLA-4 inhibitors (ipilimumab). These therapies work by blocking proteins that inhibit T-cell activity, thereby enhancing the immune system's ability to recognize and destroy cancer cells. PD-1 inhibitors prevent the PD-1 protein on T cells from binding to PD-L1 on cancer cells, which would otherwise deactivate the T cells. CTLA-4 inhibitors block the CTLA-4 protein, which downregulates immune responses. This dual blockade can lead to a more robust and sustained immune attack on melanoma cells, improving patient outcomes. Understanding these mechanisms is crucial for melanoma patients as it highlights the importance of immune system engagement in their treatment strategy.

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,458 Previous Clinical Trials
1,097,825 Total Patients Enrolled
49 Trials studying Melanoma
58,168 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,227 Previous Clinical Trials
896,312 Total Patients Enrolled
50 Trials studying Melanoma
42,583 Patients Enrolled for Melanoma

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05116202 — Phase 1 & 2
Melanoma Research Study Groups: Cohort 2: RO7247669 2100 mg + Tiragolumab, Cohort 1: RO7247669 2100 mg, Cohort 1: + Atezolizumab + Tiragolumab, Cohort 1: RO7247669 600 mg + Tiragolumab, Cohort 1: RO7247669 2100 mg + Tiragolumab, Cohort 1: RO7247669 600 mg, Cohort 1: Nivolumab + Ipilimumab
Melanoma Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT05116202 — Phase 1 & 2
Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05116202 — Phase 1 & 2
~29 spots leftby Dec 2025