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Malignant MelanomaPhase 1NCT03178851

Cobimetinib (Targeted Therapy) Plus Atezolizumab (Immunotherapy) in Participants With Advanced Melanoma Whose Cancer Has Worsened During or After Treatment With Previous Immunotherapy and Atezolizumab Monotherapy in Participants With Previously Untreated Advanced Melanoma

A Phase 1 study testing Atezolizumab and Cobimetinib in people with Malignant Melanoma, run by Hoffmann-La Roche at 43 sites in 7 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This study will evaluate the preliminary efficacy, safety, and pharmacokinetics of cobimetinib and atezolizumab in participants with advanced BRAF V600-wild type (WT), metastatic, or unresectable locally advanced melanoma who have progressed on prior anti-PD-1 therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Malignant Melanoma
What is being tested?
Atezolizumab and Cobimetinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
155 participants
Where
43 sitesin 7 countries
Study dates
20 Jun 2017to 21 Sep 2020
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Disease-Specific Inclusion Criteria: Cohorts A and B:
  • Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc BRAF V600 WT (locally advanced) melanoma
  • Documentation of BRAF V600 mutation-negative status in melanoma tumor tissue (archival [< 5 years old] or newly obtained) through use of a clinical mutation test approved by the local health authority
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
  • Disease progression on or after treatment with a programmed death (PD)-1 inhibitor either as monotherapy or in combination with other agent(s)
  • Additional Disease-Specific Inclusion Criteria in Cohort B (Biopsy Cohort):
Show all 25Show fewer
  • Progressed on or after anti-PD-1 therapy within 12 weeks before study start
  • Received a minimum of two cycles of anti-PD-1 therapy
  • Meet the following criteria for resistance to an anti-PD-1 agent: primary resistance defined as disease progression, according to RECIST v1.1, as best response; secondary resistance defined as disease progression after initial confirmed response according to RECIST v1.1
  • Consent to undergo tumor biopsies of accessible lesions, before and during treatment and at radiographic progression, for biomarker analyses.
  • Have at least two accessible lesions that are amenable to excisional or core-needle (minimum three cores and minimum diameter 18 gauge; however, 16 gauge is desirable) biopsy without unacceptable risk of a major procedural complication. Exceptions may be made if patient has only one lesion that allows multiple biopsies.
  • Disease-Specific Inclusion Criteria: Cohort C:
  • Histologically confirmed Stage IV (metastatic) or unresectable Stage IIIc BRAFV600-WT (locally advanced) melanoma
  • Naive to prior systemic anti-cancer therapy for melanoma
  • Documentation of BRAFV600 mutation-negative status in melanoma tumor tissue (archival [< 5 years old] or newly obtained) through use of a clinical mutation test approved by the local health authority
  • A representative, formalin-fixed, paraffin-embedded (FFPE) tumor specimen in a paraffin block (preferred) or 20 slides containing unstained, freshly cut, serial sections must be submitted along with an associated pathology report prior to study entry.
  • Measurable disease according to RECIST v1.1.
  • General Inclusion Criteria:
  • Ability to comply with the study protocol, in the investigator's judgment
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Available and adequate baseline tumor tissue sample
  • Life expectancy ≥ 18 weeks
  • Adequate hematologic and end-organ function, defined by laboratory test results, obtained within 14 days before initiation of study treatment
  • For women of childbearing potential: abstinent or use an effective form of contraceptive method for at least 3 months for cobimetinib and at least 5 months for atezolizumab. Women must refrain from donating eggs during this same period.
  • For men: abstinent or use contraceptive measures and agreement to refrain from donating sperm for at least 3 months after cobimetinib and atezolizumab

Who cannot join

  • Prior treatment with a mitogen activated-protein kinase (MAPK) inhibitor
  • Ocular melanoma
  • Major surgical procedure other than for diagnosis within 4 weeks before initiation of study treatment, or anticipation of need for a major surgical procedure during the course of the study
  • Traumatic injury within 2 weeks before initiation of study treatment
  • Palliative radiotherapy within 14 days before initiation of study treatment
  • Active malignancy (other than BRAF V600 mutation-negative melanoma) or malignancy within 3 years
Show all 41Show fewer
  • Treatment with any anti-cancer agent 14 days prior to Cycle, Day 1 other than aPD-1 based therapy
  • Adverse events from prior anti-cancer therapy that have not resolved to Grade ≤ 1. Clinically stable patients with manageable immune-related adverse events resulting from prior cancer immunotherapy may be eligible for the study.
  • For Cohort C only: any prior anti-cancer therapy for advanced melanoma
  • History or evidence of ongoing serous retinopathy or retinal vein occlusion (RVO) at baseline
  • History of clinically significant cardiac dysfunction
  • Active or untreated central nervous system (CNS) metastases
  • History of metastases to brain stem, midbrain, pons, or medulla, or within 10 millimeter (mm) of the optic apparatus (optic nerves and chiasm)
  • History of leptomeningeal metastatic disease
  • Human immunodeficiency virus (HIV) infection
  • Active tuberculosis
  • Severe infection within 4 weeks before initiation of study treatment
  • Signs or symptoms of infection within 2 weeks before initiation of study treatment
  • Treatment with oral or intravenous (IV) antibiotics within 2 weeks prior to Day 1 of Cycle 1
  • Active or chronic viral hepatitis B or C infection
  • Active or history of autoimmune disease or immune deficiency
  • Prior allogeneic stem cell or solid organ transplantation
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan
  • Treatment with systemic immunosuppressive medications with the following exceptions:
  • Patients who have received acute, low-dose systemic immunosuppressant medication (≤ 10 mg/day oral prednisone or equivalent) or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Medical Monitor approval has been obtained.
  • Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.
  • Current severe, uncontrolled systemic disease other than cancer
  • Any Grade >/=3 hemorrhage or bleeding event within 28 days of Day 1 of Cycle 1
  • History of stroke, reversible ischemic neurological defect, or transient ischemic attack within 6 months prior to Day 1
  • Anticipated use of any concomitant medication during or within 7 days before initiation of study treatment that is known to cause QT prolongation
  • Any psychological, familial, sociological, or geographic condition that may hamper compliance with the protocol and follow-up after treatment discontinuation
  • History of malabsorption or other clinically significant metabolic dysfunction that may interfere with absorption of oral study treatment
  • Pregnant or breastfeeding, or intending to become pregnant during the study
  • Known clinically significant liver disease
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the participant at high risk for treatment complications
  • Treatment with a live, attenuated vaccine within 4 weeks before initiation of study treatment, or anticipation of need for such a vaccine during the course of the study
  • Known hypersensitivity to any component of the atezolizumab or cobimetinib formulations
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Treatment with any other investigational agent or participation in another clinical study with therapeutic intent
  • Inability or unwillingness to swallow pills
  • Requirement for concomitant therapy or food that is prohibited during the study

Trial locations and contacts

43 sites in 7 countries.

43 sites in 7 countries

Spain9 sites

  • Hospital Universitari Quiron Dexeus

    Barcelona, 08028

  • Hospital Clinic I Provincial

    Barcelona, 08036

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Ramón y Cajal; Pharmacy

    Madrid, 28034

  • Hospital Universitario 12 de Octubre; Servicio de Oncologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Oncologia

    Madrid, 28046

  • Clínica Universidad de Navarra

    Pamplona, Navarre, 31620

  • Hospital Clinico Universitario de Santiago

    Santiago de Compostela, LA Coruña, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071

Other trials in Spain

Australia7 sites

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Blacktown Hospital

    Blacktown, New South Wales, 2148

  • Greenslopes Private Hospital; Clinic Pharmacy

    Greenslopes, Queensland, 4120

  • Peter Maccallum Cancer Centre

    Melbourne, Victoria, 3000

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Melanoma Institute Australia

    North Sydney, New South Wales, 2060

  • Mid North Coast Cancer Institute

    Port Macquarie, New South Wales, 2444

Other trials in Australia

Brazil7 sites

  • Cenantron - Centro Avancado de Tratamento Oncologico

    Belo Horizonte, Minas Gerais, 30130-090

  • Instituto de Ensino e Pesquisa Clinica do Ceara

    Fortaleza, Ceará, 60130-241

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hospital Sao Vicente de Paulo

    Passo Fundo, Rio Grande do Sul, 99010-090

  • Hospital das Clinicas - UFRGS

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Instituto Nacional de Cancer - INCa; Oncologia

    Rio de Janeiro, Rio de Janeiro, 20560-120

Other trials in Brazil

South Africa7 sites

  • Cape Town Oncology Trials

    Cape Town, 7570

  • GVI Constantiaberg

    Cape Town, 7800

  • Johese Clinical Research

    Centurion, 1692

  • Cancercare

    George, 6529

  • Wits Clinical Research; Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, 2193

  • Cancercare

    Port Elizabeth, 6045

  • Steve Biko Academic Hospital; Oncology

    Pretoria, 0002

Other trials in South Africa

United States6 sites

  • University of Colorado Hospital - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Baylor University Medical Center

    Dallas, Texas, 75231

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • HonorHealth Research Institute - Bisgrove

    Scottsdale, Arizona, 85258

  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

Ukraine5 sites

  • Public Institution: City Multispecialty Clinical Hospital #4 under Dnipropetrovsk Regional Council

    Dnipropetrovsk, 49102

  • National Cancer Institute MOH of Ukraine

    Kiev, 36022

  • Lviv State Oncology Regional Treatment and Diagnostic Centre

    Lviv, 79031

  • Sumy Regional Clinical Onc Ctr

    Sumy, 40005

  • Central Municipal Hospital - Uzhgorod State University

    Uzhhorod, Chernihiv Governorate, 88017

Other trials in Ukraine

Bosnia and Herzegovina2 sites

  • University Clinical Centre of the Republic of Srpska

    Banja Luka, 78000

  • University Clinic Ctr Sarajevo

    Sarajevo, 71 000

Other trials in Bosnia and Herzegovina

About this study

Official title: A Phase Ib Study Evaluating Cobimetinib Plus Atezolizumab in Patients With Advanced BRAF V600 Wild-Type Melanoma Who Have Progressed During or After Treatment With Anti-PD-1 Therapy and Atezolizumab Monotherapy in Patients With Previously Untreated Advanced BRAF V600 Wild-Type Melanoma

This study will evaluate the preliminary efficacy, safety, and pharmacokinetics of cobimetinib and atezolizumab in participants with advanced BRAF V600-wild type (WT), metastatic, or unresectable locally advanced melanoma who have progressed on prior anti-PD-1 therapy. In addition, this study will evaluate the efficacy, safety, and pharmacokinetics of atezolizumab monotherapy in participants with BRAFV600-WT metastatic or unresectable locally advanced melanoma, who have not been previously treated.

Being tested
Atezolizumab, Cobimetinib
Medical subject headings
Melanoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtezolizumabBiological

    Also called Tecentriq

    Atezolizumab, 840 mg intravenously every two weeks (Q2W) on Days 1 and 15 of each 28-day cycle, until loss of clinical benefit

  • CobimetinibDrug

    Also called Cotellic

    Cobimetinib, 60 mg orally once daily (QD) on Days 1-21 of each 28-day cycle, until loss of clinical benefit

  • AtezolizumabBiological

    Also called Tecentriq

    Atezolizumab, 840 mg intravenously on Day 15 of Cycle 1; thereafter Q2W on Days 1 and 15 of Cycle 2 and all subsequent 28-day cycles, until loss of clinical benefit

  • AtezolizumabBiological

    Also called Tecentriq

    Atezolizumab, 1200 mg intravenously every three weeks (Q3W) on Day 1 of each 21-day cycle, until loss of clinical benefit

Study groups in NCT03178851
Study groupRoleWhat they receive
Cohort AExperimentalParticipants with disease progression on or after treatment with an anti-PD-1 agent will receive cobimetinib and atezolizumab treatment during 28-day cycles.
Receives: Biological: Atezolizumab; Drug: Cobimetinib
Cohort BExperimentalParticipants with disease progression on or after treatment with an anti-PD-1 agent will receive cobimetinib prior to initiating atezolizumab treatment during Cycle 1. During subsequent 28-day cycles participants will initiate both atezolizumab and cobimetinib on Day 1 of each cycle. Participants in this cohort will undergo tumor biopsies before and during treatment.
Receives: Drug: Cobimetinib; Biological: Atezolizumab
Cohort CExperimentalParticipants with advanced melanoma, who have not received previous treatment, will receive atezolizumab monotherapy during 21-day cycles.
Receives: Biological: Atezolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-Assessed Objective Response Rate (ORR)

    ORR is defined as the percentage of participants with confirmed objective response (OR). Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 2 years

  2. Investigator-Assessed Disease Control Rate (DCR)

    DCR is defined as the percentage of participants with CR, PR, or stable disease (SD) at 16 weeks. Per RECIST v1.1, CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.

    Measured: Week 16

Secondary outcomes (11)

  1. Investigator-Assessed Duration of Response (DOR)

    DOR is defined as the time from the first occurrence of documented OR to disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.

    Measured: Up to approximately 2 years

  2. Overall Survival (OS)

    OS is defined as the time from Cycle 1, Day 1 to death from any cause.

    Measured: Up to approximately 2 years

  3. Investigator-Assessed Progression-Free Survival (PFS)

    PFS is defined as the time from Cycle 1, Day 1 to the first occurrence of disease progression, as determined by the investigator according to RECIST v1.1, or death from any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.

    Measured: Up to approximately 2 years

  4. Serum Concentration of Atezolizumab

    Measured: Cycle 1, Day 15; Day 1 of Cycles 2, 3, 4, 8

  5. Plasma Concentration of Cobimetinib

    Measured: Cycle 1, Day 15

  6. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline through follow up

  7. Change From Baseline in Percentage of Participants With Anti-drug Antibodies (ADAs) to Atezolizumab

    To evaluate the immune response to atezolizumab the percentage of participants with ADAs to atezolizumab will be determined at baseline and during the study.

    Measured: Cycle 1 Day 1 pre-dose to 120 days after the last dose of study medication

  8. Cohort C: Independent-Review-Committee-Assessed (IRC) ORR

    ORR is defined as the percentage of participants with confirmed objective response (OR), as determined by an independent review committee (IRC) according to RECIST v1.1. Confirmed OR is defined as complete response (CR) or partial response (PR) on two consecutive occasions ≥ 4 weeks apart, as determined by an independent review committee (IRC) according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters.

    Measured: Approximately 2 years for Cohorts A and B and 19 months for Cohort C

  9. Cohort C: IRC-Assessed DCR

    DCR is defined as the percentage of participants with CR, PR, or stable disease (SD), as determined by an independent review committee (IRC) according to RECIST v1.1. CR is defined as disappearance of all target lesions. PR is defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters. SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression, taking as reference the smallest sum on study. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline, or the appearance of one or more new lesions.

    Measured: Approximately 21 months

  10. Cohort C: IRC-Assessed DOR

    DOR is defined as the time from the first occurrence of documented OR to disease progression, as determined by an independent review committee (IRC) according to RECIST v1.1, or death from any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.

    Measured: Approximately 21 months

  11. Cohort C: IRC-Assessed PFS

    PFS is defined as the time from Cycle 1, Day 1 to the first occurrence of disease progression, as determined by an independent review committee (IRC) according to RECIST v1.1, or death from any cause, whichever occurs first. Disease progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study including baseline; or the appearance of one or more new lesions.

    Measured: Approximately 21 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jun 2017
  2. Study start20 Jun 2017
  3. Primary completion29 May 2019
  4. Study completion21 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
155 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03178851
Sponsor's protocol ID
CO39721
Other IDs
2016-004402-34, 2016
Status last verified
Nov 2021
First submitted
1 Jun 2017
Last updated
19 Nov 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Sandhu S, Atkinson V, Cao MG, Medina T, Rivas AS, Menzies AM, Caro I, Roberts L, Song Y, Yan Y, Guo Y, Xue C, Long GV. Phase 1b study of cobimetinib plus atezolizumab in patients with advanced BRAFV600 wild-type melanoma progressing on prior anti-programmed death-1 therapy. Eur J Cancer. 2023 Jan;178:180-190. doi: 10.1016/j.ejca.2022.10.019. Epub 2022 Nov 2.

    PubMed 36455412

  • Barteselli G, Goodman GR, Patel Y, Caro I, Xue C, McCallum S. Characterization of Serous Retinopathy Associated with Cobimetinib: Integrated Safety Analysis of Four Studies. Drug Saf. 2022 Dec;45(12):1491-1499. doi: 10.1007/s40264-022-01248-2. Epub 2022 Oct 30.

    PubMed 36310331

  • de Azevedo SJ, de Melo AC, Roberts L, Caro I, Xue C, Wainstein A. First-line atezolizumab monotherapy in patients with advanced BRAFV600 wild-type melanoma. Pigment Cell Melanoma Res. 2021 Sep;34(5):973-977. doi: 10.1111/pcmr.12960. Epub 2021 Feb 15.

    PubMed 33476492

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Atezolizumab and Cobimetinib in people with Malignant Melanoma, run by Hoffmann-La Roche at 43 sites in 7 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 25 inclusion and 41 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 sites in Spain, Australia, Brazil, South Africa, United States and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-Assessed Objective Response Rate (ORR) (time frame: Up to approximately 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03178851, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.

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