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Kinase Inhibitor

Cobimetinib for Ovarian Cancer

Phase 1
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline up to 48 months
Awards & highlights

Study Summary

This trial will study the safety and effectiveness of two different combinations of drugs for treating ovarian cancer.

Eligible Conditions
  • Ovarian Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline up to 48 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline up to 48 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in targeted clinical laboratory test results
Investigator-assessed confirmed objective response rate (ORR)
Number of patients reporting Adverse Events (AEs)
Secondary outcome measures
Duration of response (DOR)
Number of patients with Anti-Drug Antibodies (ADA)
Overall survival (OS)
+3 more

Side effects data

From 2024 Phase 2 trial • 86 Patients • NCT03201458
74%
Disease Progression
47%
Fatigue
35%
Aspartate aminotransferase (AST) increased
33%
Abdominal pain
33%
Diarrhea
30%
Hypertension
30%
Lymphocyte count decreased
30%
Anemia
28%
Hyponatremia
28%
Alkaline phosphatase increased
28%
Nausea
26%
Hypoalbuminemia
26%
Hypokalemia
23%
Alanine aminotransferase (ALT) increased
23%
Vomiting
21%
Fever
21%
Platelet count decreased
21%
Anorexia
21%
Cough
19%
Pain
16%
Blood bilirubin increased
16%
Constipation
16%
White blood cell decreased
14%
Dyspnea
14%
Creatinine increased
12%
Hypomagnesemia
12%
Bloating
12%
Chills
12%
Dehyrdation
12%
Weight loss
9%
Hypothyroidism
9%
Rash
9%
Dizziness
9%
Edema
9%
Headache
9%
Infusion-related reaction
9%
Hypotension
9%
Ascites
7%
Back pain
7%
Hypophosphotemia
7%
Allergic reaction
7%
Neutrophil count decreased
7%
Dyspepsia
7%
Thrush
7%
Hypercalcemia
7%
Hyperglycemia
5%
Hypocalcemia
5%
Myalgia
5%
Gastric obstruction
5%
Insomnia
5%
Malaise
5%
Proteinuria
5%
Allergic rhinitis
5%
Dysgeusia
5%
Dysphagia
5%
Flatulence
5%
Generalized muscle weakness
5%
Non-cardiac chest pain
5%
Oral pain
5%
Peripheral neuropathy
5%
Pleural effusion
5%
Pruritus
5%
Sinus tachycardia
5%
Colitis
5%
Death NOS
5%
Abdominal distension
5%
Anxiety
5%
Arthralgia
5%
Hyperhidrosis
2%
Biliary tract infection
2%
Gastroesophageal reflux disease (GERD)
2%
Presyncope
2%
Myocarditis
2%
Biliary duct obstruction
2%
Hyperkalemia
2%
Syncope
2%
Cardiac troponin increased
2%
Duodenal obstruction
2%
Lipase increased
2%
Pleuritic pain
2%
Edema limbs
2%
Encephalopathy
2%
Hypoxia
2%
Ileal obstruction
2%
Myocardial infarction
2%
Sepsis
2%
Ureteral obstruction
2%
Urinary retention
2%
Dry mouth
2%
Dry skin
2%
Sinus bradycardia
2%
Sore throat
2%
Bacteremia
2%
Fungemia
2%
Infusion related reaction
2%
Meningitis
2%
Peritoneal infection
2%
Viral infection
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm A (Atezolizumab)
Arm B (Atezolizumab, Cobimetinib)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Cohort 2 - Cobimetinib - Niraparib - AtezolizumabExperimental Treatment1 Intervention
Stage 1 - Patients in Cohort 2 will be treated with cobimetinib plus niraparib and atezolizumab. Cobimetinib: Patients will receive a starting dose of 60 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Niraparib: Patients will receive a starting dose of 200 mg of niraparib PO QD on Days 1-28 of each 28-day cycle. Atezolizumab: Patients will also receive atezolizumab administered as an IV infusion at a fixed dose of 840 mg on Days 1 and 15 (+/-3 days) of each 28-day cycle.
Group II: Cohort 1 - Cobimetinib - NiraparibExperimental Treatment1 Intervention
Stage 1 - Patients in Cohort 1 will be treated with cobimetinib plus niraparib. Cobimetinib: Patients will receive a starting dose of 60 mg by mouth (PO) daily (QD) on Days 1-21 of each 28-day cycle. Niraparib: Patients will receive a starting dose of 200 mg of niraparib PO QD on Days 1-28 of each 28-day cycle.
Group III: Arm B: Cobimetinib - Niraparib - AtezolizumabExperimental Treatment3 Interventions
Stage 2 - Patients will receive cobimetinib PO QD on Days 1-21 (21/7 schedule) in combination with niraparib QD on Days 1-28 at the established doses for the triplet regimen in Stage 1,Cohort 2 plus atezolizumab by IV infusion at the fixed dose of 840 mg on Days 1 and 15 (+/-3 days) of each 28-day cycle.
Group IV: Arm A: Cobimetinib - NiraparibExperimental Treatment2 Interventions
Stage 2 - Patients will receive cobimetinib PO QD on Days 1-21 (21/7 schedule) in combination with niraparib PO QD on Days 1-28 of each 28-day cycle at the established dose for the doublet regimen in Stage 1, Cohort 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Atezolizumab
2017
Completed Phase 3
~5860
Cobimetinib
2017
Completed Phase 3
~2660
Niraparib
2018
Completed Phase 4
~1540

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,428 Previous Clinical Trials
1,088,977 Total Patients Enrolled
16 Trials studying Ovarian Cancer
5,602 Patients Enrolled for Ovarian Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the primary medical uses of Cobimetinib?

"Cobimetinib is a common therapeutic option for small cell lung cancer (sclc) but it can also be useful in treating metastatic melanoma, unresectable malignant neoplasms and other related conditions."

Answered by AI

What precedent has been set for the use of Cobimetinib in clinical trials?

"The first clinical trial of cobimetinib took place in 2008 at SCRI Tennessee Oncology Chattanooga. Up to the present day, 118 studies have been concluded and 465 more are underway; many of which originate from Saint Louis, Missouri."

Answered by AI

What is the aim of this scientific research endeavor?

"Per the information reported by trial sponsor Hoffmann-La Roche, investigators will measure primary outcome (Investigator-assessed confirmed objective response rate) and secondary outcomes including Overall survival, Plasma concentration of cobimetinib and niraparb, and Progression-free survival over a period extending from baseline to 48 months. The efficacy profiles of Cobimetinib plus Niraparib and Cobimetinib plus Niraparib plus Atezolizumab in both investigational treatment groups will be assessed with regards to these metrics."

Answered by AI

Is recruitment for this investigation still taking place?

"Affirmative. The clinicaltrials.gov website states that the trial is actively seeking participants, which was first made available on September 1st 2019 and last updated in November 16th 2022. This investigation needs 70 people to be recruited from two distinct medical sites."

Answered by AI

What is the current participation rate for this clinical experiment?

"Affirmative. The clinical trial, which went live on 9/1/2019 and was recently updated on 11/16/2022, is actively enrolling patients at two different sites with a total goal of 70 participants."

Answered by AI

Has the FDA approved Cobimetinib as a viable treatment option?

"Our evaluation at Power rated the safety profile of cobimetinib a 1. This is due to its limited Phase 1 trial data which has not yet been sufficient enough to affirm both efficacy and safety."

Answered by AI

Is this the inaugural attempt to research this particular topic?

"According to records, 465 trials involving Cobimetinib have been active in 1786 cities and 76 countries since 2008. Sponsored by Hoffmann-La Roche, the initial clinical trial included 720 volunteers and is now at its second phase of drug approval. Since then, 118 more studies have been conducted."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer
2019. "A Clinical Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab to Patients With Advanced Platinum-sensitive Ovarian Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03695380.
~12 spots leftby Apr 2025
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