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Checkpoint Inhibitor
Immunotherapy Combinations for Melanoma
Phase 1 & 2
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 5 years
Awards & highlights
Study Summary
This trial will test different combinations of immunotherapy drugs to see if they are effective and safe in treating people with resectable Stage III melanoma or Stage IV melanoma. The study is designed to be flexible, so that new treatment arms can be added as new treatments become available, and existing treatment arms can be closed if they don't work well or have unacceptable side effects.
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.Check my eligibility
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.See study design
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 belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
I have Stage III melanoma that can be surgically removed and no recent spread to nearby skin.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization up to approximately 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization up to approximately 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response Rate (ORR) for Cohort 2
Pathologic Response Rate (pRR) for Cohort 1 as Determined by Independent Pathologic Review
Secondary outcome measures
Disease Control for Cohort 2
Duration of Delayed Surgery Due to Treatment-Related Adverse Events for Cohort 1
Duration of Response (DOR) for Cohort 2
+13 moreSide effects data
From 2019 Phase 3 trial • 1225 Patients • NCT0200822736%
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%
Neuropathy peripheral
11%
Vomiting
11%
Stomatitis
10%
Arthralgia
9%
Rash
9%
Neutrophil count decreased
8%
Dysgeusia
8%
Paraesthesia
8%
Headache
7%
Peripheral sensory neuropathy
7%
Pain in extremity
7%
Insomnia
7%
Mucosal inflammation
7%
Back pain
6%
Pneumonia
6%
Febrile neutropenia
6%
Abdominal pain
6%
Dry skin
6%
Lacrimation increased
6%
Dizziness
5%
Haemoptysis
5%
Weight decreased
5%
Malaise
5%
Urinary tract infection
5%
Nail disorder
4%
Productive cough
4%
Chest pain
4%
Nasopharyngitis
4%
Musculoskeletal pain
4%
Bronchitis
3%
Pruritus
3%
Upper respiratory tract infection
2%
Alanine aminotransferase increased
2%
Aspartate aminotransferase increased
2%
Influenza like illness
1%
Respiratory tract infection
1%
Musculoskeletal chest pain
1%
Lower respiratory tract infection
1%
Acute kidney injury
1%
Depression
1%
Lung infection
1%
Dehydration
1%
Chronic obstructive pulmonary disease
1%
Atrial fibrillation
1%
Syncope
1%
Pleural effusion
100%
80%
60%
40%
20%
0%
Study treatment Arm
Docetaxel
Atezolizumab
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
Tiragolumab
2020
Completed Phase 2
~350
Atezolizumab
2017
Completed Phase 3
~5860
Find a Location
Who is running the clinical trial?
Hoffmann-La RocheLead Sponsor
2,431 Previous Clinical Trials
1,089,732 Total Patients Enrolled
49 Trials studying Melanoma
58,168 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,201 Previous Clinical Trials
888,604 Total Patients Enrolled
50 Trials studying Melanoma
42,583 Patients Enrolled for Melanoma
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to have a sample of your tumor available for testing.I have brain metastases that are either untreated, worsening, or causing symptoms.I am fully active or restricted in physically strenuous activity but can do light work.I have had cancer spread to areas between the primary tumor and nearby lymph nodes in the last 6 months.I have high calcium levels in my blood that are causing symptoms.My melanoma is of a specific type: mucosal, uveal, or acral lentiginous.I have or had cancer spread to the lining of my brain and spinal cord.I have an immune system disorder or need medication that weakens my immune system.I haven't taken any immune-boosting drugs within the last 4 weeks or 5 half-lives before starting the study.I do not have HIV, hepatitis B, or C, or if HIV positive, I am stable on treatment with good immune function.I have had a previous transplant of stem cells or an organ.I have pain from my cancer that isn't relieved by treatment.I need frequent procedures to remove fluid from my chest, heart area, or abdomen.I have or had an autoimmune disease or immune deficiency.I am on a stable blood thinner regimen.I do not have HIV, hepatitis B, or C, or if HIV positive, I am stable on treatment with good immune function.My disease worsened after 1 or 2 treatments for its advanced stage.You need to have a sample of your tumor available for testing.I am fit and scheduled for a complete lymph node dissection.In Cohort 1, you must have a disease that can be measured using a specific set of guidelines.You have had a transplant from a donor before.My melanoma has spread to distant parts of my body.I have had radiotherapy before.I have previously received immunotherapy or other treatments for melanoma.I have an immune system disorder or need medication that weakens my immune system.You have or had a disease that affects your immune system.I haven't taken any immune-boosting drugs within the last 4 weeks or 5 half-lives before starting the study.My skin cancer is confirmed to be at the most advanced stage.I have Stage III melanoma that can be surgically removed and no recent spread to nearby skin.You have a specific type of disease that can be measured using a certain method.My blood and organs are functioning well.I haven't taken any experimental drugs in the last 28 days.I am fully active or restricted in physically strenuous activity but can do light work.My blood and organs are functioning well.I am on a stable blood thinner regimen.My melanoma is either in the mucosal areas or in the eye (uveal).
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: + Atezolizumab + Tiragolumab
- Group 2: Cohort 2: RO7247669 2100 mg + Tiragolumab
- Group 3: Cohort 1: RO7247669 2100 mg
- Group 4: Cohort 1: RO7247669 600 mg + Tiragolumab
- Group 5: Cohort 1: RO7247669 2100 mg + Tiragolumab
- Group 6: Cohort 1: RO7247669 600 mg
- Group 7: Cohort 1: Nivolumab + Ipilimumab
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has a similar research initiative ever been undertaken before?
"Globally, there are 1099 ongoing clinical studies associated with the drug RO7247669 in 76 different nations and over 2,700 cities. The initial trial for this drug was conducted by Hoffmann-La Roche back in 2008; it included 720 participants and concluded its Phase 2 approval stage. Subsequent to that time period, 441 separate trials have been held related to this medication."
Answered by AI
What discoveries have been made using RO7247669 in scientific studies?
"At present, there are 1,099 active clinical trials assessing the efficacy of RO7247669 with 153 Phase 3 experiments. While Pittsburgh Pennsylvania is a major hub for studies regarding this drug, 60,417 sites across the world have been conducting research on it."
Answered by AI
Are there opportunities for new participants to join this research?
"Clinicaltrials.gov affirms that this medical research, which was initially posted on February 2nd 2022 and updated most recently on December 1st 2022, is still seeking out suitable candidates."
Answered by AI
What is the total cohort size for this clinical trial?
"Affirmative. The data hosted on clinicaltrials.gov implies that this trial is currently seeking participants, which first appeared on February 2nd 2022 and was last updated December 1st of the same year. There are six enrolment sites looking to fill 191 vacancies in total."
Answered by AI
What is the total number of healthcare facilities currently participating in this experiment?
"Currently, this study is recruiting out of 6 locations spread throughout the US. These sites are located in Los Angeles, Santa Monica and Houston as well as other cities. To reduce potential travel burdens for participants, it may be wise to pick a nearby centre if accepted into the trial."
Answered by AI
What medical conditions are typically treated with RO7247669?
"RO7247669 is routinely used to combat malignant neoplasms, but can also help treat unresectable melanoma, squamous cell carcinomas and other conditions characterized by a high risk of recurrence."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
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