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Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

A Phase II, Open-Label, Single-Arm, Multi-Cohort, Proof-of-Principle Study to Investigate the Efficacy of Cobimetinib and Atezolizumab in Advanced Rare Tumors

NCT03108131•M.D. Anderson Cancer Center

View on ClinicalTrials.gov

Summary

This phase II trial studies how well cobimetinib and atezolizumab work in treating participants with rare tumors that have spread to other places in the body (advanced) or that does not respond to treatment (refractory). Cobimetinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Immunotherapy with monoclonal antibodies, such as atezolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Giving cobimetinib and atezolizumab may work better in treating participants with advanced or refractory rare tumors.

Detailed Description

PRIMARY OBJECTIVE: I. To evaluate the efficacy of cobimetinib plus atezolizumab (COTEZO) in cohorts of advanced rare tumors using objective response rate (ORR) per Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1. SECONDARY OBJECTIVES: I. To determine progression-free survival (PFS) on COTEZO in cohorts of advanced rare tumors per RECIST v1.1 and immune-related (ir)RECIST. II. To determine overall survival (OS) on COTEZO in cohorts of advanced rare tumors. III. To determine disease control rate (DCR) and duration of response (DOR) on COTEZO in cohorts of advanced rare tumors per RECIST v1.1 and irRECIST. IV. To determine objective response rate (ORR) per immune-related RECIST criteria. V. To determine safety profile and adverse events encountered by patients with advanced rare tumors treated with COTEZO. VI. To collect and bank tumor tissue and peripheral blood for future correlative analyses from patients with advanced rare tumors treated with COTEZO. OUTLINE: Participants receive cobimetinib orally (PO) once daily (QD) on days 1-21 and atezolizumab intravenously (IV) over 60 minutes on days 1 and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, participants followed up every 3 months thereafter.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients must be informed of the investigational nature of this study and must be willing to give written informed consent in accordance with institutional and federal guidelines. Patients must be able to comply with the requirements and assessments of the study protocol
•Must have histologically or cytologically documented rare tumor as defined per protocol that is metastatic or locally advanced and unresectable. Patients with locally advanced cutaneous squamous cell carcinoma that are technically resectable but in whom surgery is expected to lead to substantial function impairment or disfigurement are eligible
•Must be refractory or intolerant to standard lines of therapy
•Must have completed prior chemotherapy, immunotherapy, or radiation therapy at least 14 days prior to start of treatment and all toxicity must be resolved to Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grade 1 (with the exception of CTCAE v4.0 grade 2 neuropathy) prior to start of treatment
•Presence of radiographically evaluable disease
•Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
•Tissue Parameters: a. Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks are preferred) or at least 4 unstained slides, with an associated pathology report, for testing of tumor PD-L1 expression (tumor tissue from bone metastases is not evaluable for PD-L1 expression and is therefore not acceptable). b. Tumor tissue should be of good quality based on total and viable tumor content. Fine needle aspiration, brushing, cell pellet from pleural effusion, bone metastases, and lavage samples are not acceptable. For core-needle biopsy specimens, at least three cores should be submitted for evaluation. c. Patients who do not have tissue specimens meeting eligibility requirements must be willing to undergo a biopsy during the screening period
•Absolute neutrophil count (ANC) \>= 1,000/mcL (obtained within 14 days prior to enrollment)
•Platelets \>= 75,000/mcL (obtained within 14 days prior to enrollment)
•Hemoglobin \>= 9 g/dL (obtained within 14 days prior to enrollment)
+13 more criteria

Exclusion Criteria

•Presence of brain metastases (unless they have been adequately treated with radiotherapy or surgery and stable for at least 30 days prior to enrollment provided patient is neurologically asymptomatic and without corticosteroid treatment for at least 7 days prior to enrollment)
•Uncontrolled intercurrent illness including, but not limited to diabetes, hypertension, severe infection, severe malnutrition, unstable angina, class III-IV New York Heart Association (NYHA) congestive heart failure, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within 6 months prior to enrollment
•History of or evidence of retinal pathology on ophthalmologic examination that is considered a risk factor for neurosensory retinal detachment, central serous chorioretinopathy, retinal vein occlusion (RVO), or neovascular macular degeneration
•Patients will be excluded from study participation if they currently are known to have any of the following risk factors for RVO: a. Glaucoma with intraocular pressure \>= 21 mmHg b. Grade \>= 2 serum cholesterol c. Grade \>= 2 hypertriglyceridemia d. Grade \>= 2 or symptomatic hyperglycemia (fasting) e. Grade \>= 2 uncontrolled hypertension (patients with a history of hypertension controlled with anti-hypertensive medication to grade =\< 1 are eligible)
•Active malignancy (other than colorectal carcinoma \[CRC\]) or a history of prior malignancy within the past 3 years. Adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ, other low grade lesions such as incidental appendix carcinoid, or any other cancer from which the patient has been disease and treatment free for two years are allowed. Prostate cancer patients on active surveillance are eligible
•Pregnant or nursing patients due to risk of fetal or nursing infant harm. Women/men of reproductive potential who do not agree to use an effective contraceptive method while on study and for at least 6 months after study treatment
•Left ventricular ejection fraction (LVEF) \< institutional lower limit of normal or \< 50%
•History or risk of autoimmune disease, including but not limited to systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis a. Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible. b. Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible. c. Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
•* Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
•* Rash must cover less than 10% of body surface area (BSA)
+15 more criteria

Locations (1)

M D Anderson Cancer Center

Houston, Texas, United States

Key Dates

Start Date

April 7, 2017

Primary Completion Date

April 2, 2024

Completion Date

April 2, 2024

Last Updated

May 28, 2025

Enrollment

ACTUAL participants

Conditions

Skin Squamous Cell CarcinomaAppendix AdenocarcinomaRare LesionLocally Advanced Malignant NeoplasmLocally Advanced Skin Squamous Cell CarcinomaMetastatic Malignant NeoplasmMetastatic Skin Squamous Cell CarcinomaMetastatic Small Intestinal AdenocarcinomaRare Neoplastic SyndromeRefractory Malignant NeoplasmStage IV Small Intestinal Adenocarcinoma AJCC v8Unresectable Malignant Neoplasm

Interventions

Atezolizumab

DRUG

Cobimetinib

DRUG

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System

NCT07042295

Locally Recurrent Skin Squamous Cell CarcinomaMetastatic Skin Squamous Cell Carcinoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cobimetinib and Atezolizumab in Treating Participants With Advanced or Refractory Rare Tumors

Inclusion Criteria

Exclusion Criteria

Treatment With Amivantamab and Hyaluronidase or Cetuximab for Advanced Skin Cancer in People With a Weakened Immune System

Intratumoral Injection of Standard Universal Donor Expanded Natural Killer Cells and TGF-beta Imprinted Natural Killer Cells for the Treatment of Skin Squamous Cell Carcinoma and Basal Cell Carcinoma

Pembrolizumab in Treating Patients With Rare Tumors That Cannot Be Removed by Surgery or Are Metastatic

Talimogene Laherparepvec and Panitumumab for the Treatment of Locally Advanced or Metastatic Squamous Cell Carcinoma of the Skin

Study of Nanrilkefusp Alfa Alone and With Pembrolizumab in Adult Patients With Advanced/Metastatic Solid Tumors