A MolEcularly Guided Anti-Cancer Drug Off-Label Trial (MEGALiT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04185831|
Recruitment Status : Not yet recruiting
First Posted : December 4, 2019
Last Update Posted : December 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumor||Drug: Atezolizumab Drug: Everolimus Drug: Niraparib Drug: Cobimetinib||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||154 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Combined umbrella and basket trial. Treatment selection based on mutation status.|
|Masking:||None (Open Label)|
|Official Title:||MEGALiT - a Multicenter, Basket and Umbrella Explorative Trial on the Efficacy and Safety of Molecular Profile Selected Commercially Available Targeted Anti-cancer Drugs in Patients With Advanced Cancers Progressive on Standard Therapy|
|Estimated Study Start Date :||January 2020|
|Estimated Primary Completion Date :||December 2022|
|Estimated Study Completion Date :||December 2022|
Niraparib, 300mg po twice daily.
Other Name: Zejula
Cobimetinib, 60mg po daily. 28 day cycle; day 1-21 60mg daily, day 22-28 rest period.
Other Name: Cotellic
Everolimus, 10mg po daily.
Other Name: Afinitor
Experimental: Mutation burden
Atezolizumab. 1200mg iv every 3 weeks.
Other Name: Tecentriq
- Objective Response Rate (ORR) and tumor control rate [Time Frame: From first dose up to 24 months] [ Time Frame: 1 year follow-up after LPFV ]The proportion of patients that have a best overall response of complete response (CR), partial response (PR) or stable disease ≥16 weeks, as assessed by RECIST 1.1 criteria
- Additional measurements of treatment efficacy [ Time Frame: 1 year follow-up after LPFV ]Time to and duration of tumor response and stable disease, progression free survival, overall survival and progression free survival on study drug compared with that on the treatment preceding study drug treatment.
- Drug-related safety, evaluated according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03 [ Time Frame: 1 year follow-up after LPFV ]Incidence and severity of study drug related adverse events (AEs) and serious adverse events (SAEs). Include recording of changes in laboratory values, vital signs (body temperature, blood pressure, heart rate, respiratory rate), and assessment of physical, dermatological examinations graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.03.
- Biopsy safety: NCI Common Terminology Criteria for Adverse Events 4.03 as grade 3 - 4 adverse event related to the procedure [ Time Frame: 1 year follow-up after LPFV ]Safety of core needle biopsy in advanced cancer scored according to NCI Common Terminology Criteria for Adverse Events 4.03 as grade 3 - 4 adverse event related to the procedure.
- Genomic analysis [ Time Frame: 1 year follow-up after LPFV ]Actionable target concordance between genomic analysis results from the Foundation Medicine platform F1CDx with that from the similar local analysis.
- Overall survival [ Time Frame: 1 year follow-up after LPFV ]Overall survival of patients starting treatment in accordance with 1 of the 4 groups of genomic markers compared with patients included in the trial but that do not start such treatment due to lack of appropriate marker.
- Feasibility of study design [ Time Frame: 1 year follow-up after LPFV ]Feasibility of comprehensive genomic testing of fresh tumor tissue for treatment decision, defined as the proportion of patients included with actionable genomic analysis within 4 weeks from inclusion
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04185831
|Contact: Hannah Karlsson, PhDfirstname.lastname@example.org|
|Sahlgrenska University Hospital|
|Contact: Lars Ny, MD, PhD email@example.com|
|Principal Investigator: Lars Ny, MD, PhD|
|Skane University Hospital|
|Contact: Ana Carneiro, MD, PhD firstname.lastname@example.org|
|Principal Investigator: Ana Carneiro, MD, PhD|
|Uppsala University Hospital|
|Contact: Hannah Karlsson, PhD +46186171654 email@example.com|
|Principal Investigator: Joakim Crona, MD, PhD|
|Principal Investigator:||Peter Nygren, MD, PhD||Uppsala University Hospital|
|Study Director:||Peter Asplund, BSc||Uppsala University Hospital|