← Back to Search

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 2: Histologically confirmed Stage IV (metastatic) cutaneous melanoma according to AJCC-8
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization up to approximately 5 years
Awards & highlights
No Placebo-Only Group

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 below
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My skin cancer is confirmed to be at the most advanced stage.
Select...
My disease worsened after 1 or 2 treatments for its advanced stage.
Select...
I do not have HIV, hepatitis B, or C, or if HIV positive, I am stable on treatment with good immune function.
Select...
I am on a stable blood thinner regimen.
Select...
I do not have HIV, hepatitis B, or C, or if HIV positive, I am stable on treatment with good immune function.
Select...
I have Stage III melanoma that can be surgically removed and no recent spread to nearby skin.
Select...
I am fit and scheduled for a complete lymph node dissection.
Select...
My blood and organs are functioning well.
Select...
I am fully active or restricted in physically strenuous activity but can do light work.
Select...
My blood and organs are functioning well.
Select...
I am on a stable blood thinner regimen.

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

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 more

Side effects data

From 2019 Phase 3 trial • 1225 Patients • NCT02008227
27%
Fatigue
25%
Decreased appetite
24%
Cough
19%
Dyspnoea
19%
Asthenia
18%
Constipation
18%
Pyrexia
18%
Nausea
16%
Diarrhoea
13%
Arthralgia
12%
Vomiting
12%
Anaemia
11%
Back pain
11%
Musculoskeletal pain
11%
Rash
10%
Headache
9%
Oedema peripheral
9%
Weight decreased
9%
Chest pain
9%
Insomnia
9%
Pruritus
9%
Pain in extremity
8%
Dizziness
7%
Upper respiratory tract infection
7%
Aspartate aminotransferase increased
7%
Myalgia
7%
Haemoptysis
6%
Influenza like illness
6%
Nasopharyngitis
6%
Alanine aminotransferase increased
6%
Bronchitis
6%
Productive cough
5%
Musculoskeletal chest pain
5%
Depression
5%
Dry skin
4%
Abdominal pain
4%
Urinary tract infection
4%
Neuropathy peripheral
4%
Paraesthesia
3%
Stomatitis
3%
Dysgeusia
3%
Pneumonia
2%
Malaise
2%
Pleural effusion
2%
Neutropenia
1%
Lacrimation increased
1%
Respiratory tract infection
1%
Sepsis
1%
Pneumonitis
1%
Mucosal inflammation
1%
Bone pain
1%
Pulmonary embolism
1%
Peripheral sensory neuropathy
1%
Alopecia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Atezolizumab
Docetaxel

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
Atezolizumab
2016
Completed Phase 3
~6040
Tiragolumab
2020
Completed Phase 1
~90

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,423 Previous Clinical Trials
1,081,593 Total Patients Enrolled
49 Trials studying Melanoma
58,168 Patients Enrolled for Melanoma
Clinical TrialsStudy DirectorHoffmann-La Roche
2,196 Previous Clinical Trials
888,072 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 600 mg, Cohort 1: RO7247669 600 mg + Tiragolumab, Cohort 1: RO7247669 2100 mg + Tiragolumab, Cohort 1: RO7247669 2100 mg, Cohort 1: Nivolumab + Ipilimumab, Cohort 1: + Atezolizumab + Tiragolumab
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

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
~96 spots leftby Jan 2025