Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer
INVICTAN®-3
A Single Arm, Open-label, Multicenter, Multinational, Safety and Efficacy Phase IIIb Trial of BI 695502 Plus mFOLFOX6 in Patients With Previously Untreated Metastatic Colorectal Cancer
2 other identifiers
interventional
123
4 countries
46
Brief Summary
The objective of this trial is to evaluate the safety and tolerability of BI 695502 in combination with leucovorin/5-fluorouracil/oxaliplatin (mFOLFOX6) and as maintenance therapy (when applicable). As well as to evaluate the following efficacy parameters: Progression-free survival (PFS), objective response rate (proportion of patients with complete response \[CR\] plus partial response \[PR\]), overall survival (OS), duration of response (DOR), time to progression (TTP).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jun 2016
46 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 18, 2016
CompletedStudy Start
First participant enrolled
June 8, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 3, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 3, 2018
CompletedResults Posted
Study results publicly available
November 21, 2019
CompletedNovember 21, 2019
October 1, 2019
2.3 years
May 17, 2016
October 2, 2019
November 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment
The primary safety endpoint of the trial was patients with any of the following selected adverse events (AEs): * Infusion reactions (anaphylactic/hypersensitivity/infusion-related reactions), * Thromboembolic events (arterial or venous), * Gastrointestinal perforations, * Hypertension, * Proteinuria, * Pulmonary hemorrhage * All hemorrhages (including pulmonary hemorrhages) * Wound-healing complications/abscess/fistulas * Posterior reversible encephalopathy syndrome * Ovarian failure. All AEs with an onset between start of treatment and end of the residual effect period (REP), a period of 18 weeks after the last dose of trial medication were considered for the primary safety analysis. Confidence interval was calculated using Wilson score method.
From baseline up to 18 weeks after the last dose of trial medication prior to the Switch Visit. Maximum duration of up to 32 treatment cycles + safety follow up (up to 82 weeks overall).
Secondary Outcomes (5)
Duration of Response (DOR) as Assessed by Central Imaging Review
Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
Time to Progression (TTP) as Assessed by Central Imaging Review
Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
Objective Response (OR) Rate as Assessed by Central Imaging Review
Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
Overall Survival (OS) Time
From date of first dose of trial medication until last date of trial medication + 18 weeks (REP), up to a maximum of 32 treatment cycles + safety follow up (up to 82 weeks overall).
Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review
Tumor scans were performed at baseline then every ~8 weeks up to 34 weeks, then every ~12 weeks thereafter until confirmed disease progression. Analysis performed for the pre-switch period only; maximum duration of up to 32 treatment cycles (64 weeks).
Study Arms (1)
All patients
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- Males and females aged \>=18 years (for Japan only: Age \>=20 years at time of signing Informed Consent Form) with histologically confirmed metastatic colorectal cancer (mCRC).
- Metastatic disease not amenable to surgical curative treatment and eligible to receive therapy with mFOLFOX6 (Leucovorin/5-Fluorouracil/Oxaliplatin) + bevacizumab.
- At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1.
- Adequate hepatic, renal and bone marrow function.
You may not qualify if:
- Prior systemic therapy for metastatic disease
- Prior therapy with monoclonal antibodies or small molecule inhibitors against Vascular endothelial growth factor (VEGF) or VEGF receptors, including Avastin® or Avastin® biosimilar
- Previous malignancy other than Colorectal cancer (CRC) in the last 5 years except for basal cell cancer of the skin or pre-invasive cancer of the cervix
- Spinal cord compression or brain metastases unless asymptomatic, stable and not requiring steroids for at least 6 weeks prior to start of study treatment
- Any unresolved toxicity \> Common Toxicity Criteria Grade 1 (except alopecia) from previous anticancer therapy (including radiotherapy)
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding
- A thrombotic or hemorrhagic event \<=6 months prior to screening (includes hemoptysis, Gastrointestinal (GI) bleeding, hematemesis, central nervous system hemorrhage, epistaxis, vaginal bleeding, cerebral infarction, transient ischemic attacks, myocardial infarction, angina, and coronary artery disease)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (46)
Mayo Clinic-Arizona
Phoenix, Arizona, 85054, United States
Pacific Cancer Medical Center, Inc.
Anaheim, California, 92801, United States
The Oncology Institute of Hope and Innovation
Anaheim, California, 92801, United States
Rocky Mountain Cancer Centers
Denver, Colorado, 80218, United States
Ashland Bellefonte Cancer Center
Ashland, Kentucky, 41101, United States
University of Michigan Health System
Ann Arbor, Michigan, 48109, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Oncology Hematology Care
Cincinnati, Ohio, 45242, United States
Northwest Cancer Specialists PC
Portland, Oregon, 97225, United States
Willamette Valley Cancer Institute and Research Center
Springfield, Oregon, 97477, United States
Texas Oncology, P.A.
Abilene, Texas, 79606, United States
Texas Oncology, PA,
Amarillo, Texas, 79106, United States
Texas Oncology, P.A.
Austin, Texas, 78705, United States
Texas Oncology, P.A.
Flower Mound, Texas, 75028, United States
Texas Oncology, P.A.
Garland, Texas, 75042-5788, United States
Oncology Consultants, P.A.
Houston, Texas, 77030, United States
Texas Oncology, P.A.
McAllen, Texas, 78503-1298, United States
Texas Oncology, PA
Mesquite, Texas, 75150, United States
Texas Oncology-San Antonio Northeast
San Antonio, Texas, 78217, United States
Texas Oncology San Antonio Medical Center
San Antonio, Texas, 78229, United States
Tyler Hematology-Oncology, PA
Tyler, Texas, 75701, United States
Texas Oncology, P.A.
Tyler, Texas, 75702, United States
Texas Oncology, P.A., Deke Slayton Cancer Center
Webster, Texas, 77598, United States
Virginia Cancer Institute
Richmond, Virginia, 23226, United States
Chiba Cancer Center
Chiba, Chiba, 260-8717, Japan
National Hospital Organization Shikoku Cancer Center
Ehime, Matsuyama, 791-0280, Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648, Japan
Japan Organization of Occupational Health and Safety Kansai Rosai Hospital
Hyogo, Amagasaki, 660-8511, Japan
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793, Japan
Osaka University Hospital
Osaka, Suita, 565-0871, Japan
Jananese Foundation for Cancer Research
Tokyo, Koto-ku, 135-8550, Japan
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08907, Spain
Hospital ClĂnico de Valencia
Valencia, 46010, Spain
CI Chernivtsi RC Oncological Dispensary Bukovinian SMU
Chernivtsi, 58013, Ukraine
Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council
Dnipropetrovsk, 49102, Ukraine
Regional Clinical Oncological Dispensary, Ivano-Frankivsk
Ivano-Frankivsk, 76018, Ukraine
CI of PH Kharkiv CCH #2
Kharkiv, 61037, Ukraine
Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad
Kirovohrad, 25006, Ukraine
CI Kryvyi Rih Oncological Dispensary of DRC
Kryvyi Rih, Dnipropetrovsk, 50048, Ukraine
National Institute of Cancer
Kyiv, 03022, Ukraine
CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.
Lviv, 79031, Ukraine
Poltava Regional Clinical Oncological Dispensary, Poltava
Poltava, 38011, Ukraine
Sumy Regional Oncology Center
Sumy, 40022, Ukraine
Vinnytsia Regional Clinical Oncological Dispensary
Vinnytsia, 21029, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
From 21 December 2017, the Sponsor recommended for patients to be switched from BI 695502 to Avastin®. The main analyses for reporting primary and secondary endpoints was clarified as the pre-switch period (i.e., all receiving BI 695502).
Results Point of Contact
- Title
- Boehringer Ingelheim, Call Centre
- Organization
- Boehringer Ingelheim
Study Officials
- STUDY CHAIR
Boehringer Ingelheim
Boehringer Ingelheim
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 18, 2016
Study Start
June 8, 2016
Primary Completion
October 3, 2018
Study Completion
October 3, 2018
Last Updated
November 21, 2019
Results First Posted
November 21, 2019
Record last verified: 2019-10