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Colorectal NeoplasmsPhase 3INVICTAN®-3NCT02776683

Open-label, Single Arm Trial of BI 695502 in Patients With Previously Untreated Metastatic Colorectal Cancer

A Phase 3 study testing BI 695502 and Avastin in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 46 sites in 4 countries.

Completed

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

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Neoplasms
What is being tested?
BI 695502 and Avastin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
123 participants
Where
46 sitesin 4 countries
Study dates
8 Jun 2016to 3 Oct 2018
Phase
Phase 3
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

  • 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.
  • Further inclusion criteria apply.

Who cannot join

  • 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)
  • Further exclusion criteria apply

Trial locations and contacts

46 sites in 4 countries.

46 sites in 4 countries

United States25 sites

  • Texas Oncology, P.A.

    Abilene, Texas, 79606

  • Texas Oncology, PA,

    Amarillo, Texas, 79106

  • Pacific Cancer Medical Center, Inc.

    Anaheim, California, 92801

  • The Oncology Institute of Hope and Innovation

    Anaheim, California, 92801

  • University of Michigan Health System

    Ann Arbor, Michigan, 48109

  • Ashland Bellefonte Cancer Center

    Ashland, Kentucky, 41101

  • Texas Oncology, P.A.

    Austin, Texas, 78705

  • Aultman Hospital

    Canton, Ohio, 44710

  • Oncology Hematology Care

    Cincinnati, Ohio, 45242

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Texas Oncology, P.A.

    Flower Mound, Texas, 75028

  • Texas Oncology, P.A.

    Garland, Texas, 75042-5788

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

  • Texas Oncology, P.A.

    McAllen, Texas, 78503-1298

  • Texas Oncology, PA

    Mesquite, Texas, 75150

  • Mayo Clinic-Arizona

    Phoenix, Arizona, 85054

  • Northwest Cancer Specialists PC

    Portland, Oregon, 97225

  • Virginia Cancer Institute

    Richmond, Virginia, 23226

  • Texas Oncology-San Antonio Northeast

    San Antonio, Texas, 78217

  • Texas Oncology San Antonio Medical Center

    San Antonio, Texas, 78229

  • Willamette Valley Cancer Institute and Research Center

    Springfield, Oregon, 97477

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Tyler Hematology-Oncology, PA

    Tyler, Texas, 75701

  • Texas Oncology, P.A.

    Tyler, Texas, 75702

  • Texas Oncology, P.A., Deke Slayton Cancer Center

    Webster, Texas, 77598

Other trials in United States

Ukraine11 sites

  • CI Chernivtsi RC Oncological Dispensary Bukovinian SMU

    Chernivtsi, 58013

  • Munic.Instit."City Clin.Hosp.#4" of Dnipro City Council

    Dnipropetrovsk, 49102

  • Regional Clinical Oncological Dispensary, Ivano-Frankivsk

    Ivano-Frankivsk, 76018

  • CI of PH Kharkiv CCH #2

    Kharkiv, 61037

  • Treatment-Diagnostic CTR of Private Enterprise, Kirovohrad

    Kirovohrad, 25006

  • CI Kryvyi Rih Oncological Dispensary of DRC

    Kryvyi Rih, Dnipropetrovsk, 50048

  • National Institute of Cancer

    Kyiv, 03022

  • CI of LRC Lviv Onco.Reg.Treat.&Diag.Cent.

    Lviv, 79031

  • Poltava Regional Clinical Oncological Dispensary, Poltava

    Poltava, 38011

  • Sumy Regional Oncology Center

    Sumy, 40022

  • Vinnytsia Regional Clinical Oncological Dispensary

    Vinnytsia, 21029

Other trials in Ukraine

Japan7 sites

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Hospital Organization Shikoku Cancer Center

    Ehime, Matsuyama, 791-0280

  • Hokkaido University Hospital

    Hokkaido, Sapporo, 060-8648

  • Japan Organization of Occupational Health and Safety Kansai Rosai Hospital

    Hyogo, Amagasaki, 660-8511

  • Kagawa University Hospital

    Kagawa, Kita-gun, 761-0793

  • Osaka University Hospital

    Osaka, Suita, 565-0871

  • Jananese Foundation for Cancer Research

    Tokyo, Koto-ku, 135-8550

Other trials in Japan

Spain3 sites

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Duran i Reynals

    L'Hospitalet de Llobregat, 08907

  • Hospital Clínico de Valencia

    Valencia, 46010

Other trials in Spain

About this study

Official title: 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

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).

Being tested
BI 695502, Avastin
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • BI 695502Drug

  • AvastinDrug

Study groups in NCT02776683
Study groupRoleWhat they receive
All patientsExperimentalNot described
Receives: Drug: BI 695502; Drug: Avastin

What is being measured

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

  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.

    Measured: 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)

  1. Duration of Response (DOR) as Assessed by Central Imaging Review

    DOR was the time from first documented Complete Response (CR) (CR is disappearance of all target lesions) or Partial Response (PR) (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) until time of progression as assessed by central imaging review per Response evaluation criteria in solid tumors (RECIST) 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. DOR was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.

    Measured: 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).

  2. Time to Progression (TTP) as Assessed by Central Imaging Review

    TTP was defined as the time from first administration of trial medication to the date of tumor progression as assessed by central imaging review per RECIST 1.1 (RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment.). TTP was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.

    Measured: 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).

  3. Objective Response (OR) Rate as Assessed by Central Imaging Review

    OR rate was defined as the percentage of patients who achieved at least one visit response of CR (CR is disappearance of all target lesions) or PR (PR is at least a 30% decrease in the sum of diameters (SoD) of target lesions taking as reference the baseline sum diameters) after the start of treatment. The response criteria evaluation was carried out according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Confidence interval was calculated using Wilson score method. The definition for OR (CR/PR) extends until disease progression/ death/ unacceptable toxicity/ end of the trial, whichever occurred earlier. However for "Duration of response" this censoring does not apply. Hence the apparent discrepancy.

    OR = CR + PR.

    Measured: 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).

  4. Overall Survival (OS) Time

    OS was defined as the time from first administration of trial medication until death from any cause. OS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.

    Measured: 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).

  5. Progression-Free Survival (PFS) Time as Assessed by Central Imaging Review

    PFS was defined as the time from first administration of trial medication until disease progression as assessed by central imaging review or death due to any cause. Disease progression was assessed according to RECIST 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Progression was defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also have demonstrated an absolute increase of at least 5 mm. PFS was calculated using the Kaplan-Meier technique. Confidence interval was calculated based on the Brookmeyer and Crowley method.

    Measured: 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).

Timeline

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

  1. First posted18 May 2016 (estimated)
  2. Study start8 Jun 2016
  3. Primary completion3 Oct 2018
  4. Study completion3 Oct 2018

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
123 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02776683
Sponsor's protocol ID
1302.3
Other IDs
2015-003718-25, 2015
Acronym
INVICTAN®-3
Status last verified
Oct 2019
First submitted
17 May 2016
Last updated
21 Nov 2019

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BI 695502 and Avastin in people with Colorectal Neoplasms, run by Boehringer Ingelheim at 46 sites in 4 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 6 inclusion and 8 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 21 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 46 sites in United States, Ukraine, Japan, Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 21 Nov 2019). 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?

Percentage of Patients With Treatment-Emergent Adverse Events (TEAEs) in the Specified Categories Selected for Primary Endpoint Assessment (time frame: 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).). 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 NCT02776683.

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 21 Nov 2019.

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