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Colorectal CancerPhase 2NCT04126733

Study on the Effectiveness and Safety of the Combination of the Two Drugs Regorafenib and Nivolumab in Patients With Colorectal Cancer (Cancer of the Colon or Rectum Classified as Proficient Mismatch Repair and Microsatellite Stable)

A Phase 2 study testing Regorafenib (Stivarga, BAY73-4506) and Nivolumab (Opdivo) in people with Colorectal Cancer, run by Bayer at 15 sites in United States.

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 purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
Regorafenib (Stivarga, BAY73-4506) and Nivolumab (Opdivo)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
15 sitesUnited States
Study dates
14 Oct 2019to 28 Mar 2022
Phase
Phase 2
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

  • Histological or cytological confirmed advanced, metastatic, or progressive pMMR/MSS adenocarcinoma of colon or rectum
  • Participant must have progressed or be intolerant to prior systemic chemotherapy including fluoropyrimidines, irinotecan, oxaliplatin, anti-vascular endothelial growth factor (VEGF) therapy, and, if extended rat sarcoma viral oncogene homolog (RAS) wild type, an anti-epidermal growth factor receptor (EGFR) therapy. Exceptions may apply
  • Participants must have adequate organ and marrow function defined by protocol-specified laboratory tests
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
  • Measurable disease as determined by response evaluation criteria in solid tumors (RECIST) v1.1
  • Provision of recently obtained tumor tissue as per protocol specified requirement
  • Anticipated life expectancy greater than 3 months
  • Be able to swallow and absorb oral tablets

Who cannot join

  • Participants with Mismatch repair deficient (dMMR) / microsatellite instable-high (MSI-H) colorectal cancer
  • Prior therapy with regorafenib, anti-programmed cell death protein 1 (PD-1), programmed cell death protein 1 ligand 1 (PD-L1), or cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, or any form of immunotherapy to treat cancer
  • Presence of active central nervous system (CNS) metastases; participants with stable CNS disease or previously treated lesions are eligible for study entry
  • Poorly controlled hypertension, defined as a blood pressure consistently above 150/90 mmHg despite optimal medical management
  • Arterial thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks) within 6 months before the start of study medication. Active pulmonary emboli or deep vein thrombosis that are significant or not adequately controlled on anticoagulation regimen
  • Any hemorrhage or bleeding event ≥ National Cancer Institute - Common terminology criteria for adverse events (NCI-CTCAE) Grade 3 within 28 days prior to the start of study medication
Show all 10Show fewer
  • Participants with an active, known or suspected autoimmune disease
  • History of interstitial lung disease or pneumonitis
  • Known history of human immunodeficiency virus (HIV) infection or current chronic or active hepatitis B or C infection
  • Other protocol defined inclusion/exclusion criteria could apply

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

United States15 sites

  • New York Oncology Hematology. P.C.

    Albany, New York, 12206

  • Texas Oncology-Arlington North

    Arlington, Texas, 76012

  • Illinois Cancer Specialists

    Arlington Heights, Illinois, 60005

  • Baylor Charles A. Sammons Cancer Center at Dallas

    Dallas, Texas, 75246

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • City of Hope National Medical Center

    Duarte, California, 91010

  • Willamette Valley Cancer Institute and Research Center

    Eugene, Oregon, 97401

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Miami Cancer Institute at Baptist Health South Florida

    Miami, Florida, 33176

  • Minnesota Oncology Hematology, PA

    Minneapolis, Minnesota, 55404

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Nebraska Cancer Specialists

    Papillion, Nebraska, 68046

  • Texas Oncology-Sherman

    Sherman, Texas, 75090

  • Northwest Cancer Specialists, PC

    Vancouver, Washington, 98684

Other trials in United States

About this study

Official title: An Open-label, Single-arm, Phase II Study of Regorafenib and Nivolumab in Patients With Mismatch Repair-Proficient (pMMR)/Microsatellite Stable (MSS) Colorectal Cancer (CRC)

The purpose of this study is to learn if combination of the two drugs regorafenib and nivolumab is an effective treatment for pMMR - MSS colorectal cancer, a special type of cancer of the colon or rectum (pMMR stands for proficient Mismatch Repair; MSS stands for Microsatellite Stable) and whether it is safe for patients. Regorafenib works by blocking several different proteins involved in tumor growth. Nivolumab is an immunotherapy drug encouraging the body's own immune system to attack cancer cells.

Both drugs have been approved, but not for how they are being used as combination therapy in this study. Brand name of regorafenib is Stivarga; brand name of nivolumab is Opdivo.

Being tested
Regorafenib (Stivarga, BAY73-4506), Nivolumab (Opdivo)
Medical subject headings
Colorectal Neoplasms

What participants receive

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

  • Regorafenib (Stivarga, BAY73-4506)Drug

    Regorafenib administered as oral tablets given every day for 3 weeks of each 28 days treatment cycle (i.e., 3 weeks on, 1 week off)

  • Nivolumab (Opdivo)Biological

    Administered on day 1 of every treatment cycle.

Study groups in NCT04126733
Study groupRoleWhat they receive
Regorafenib + NivolumabExperimentalNot described
Receives: Drug: Regorafenib (Stivarga, BAY73-4506); Biological: Nivolumab (Opdivo)

What is being measured

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

  1. Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 Assessed by Investigator

    ORR was defined as the percentage of participants with overall response of complete response (CR) or partial response (PR).

    CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of < 10 mm.

    PR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

    Measured: Through database cut-off date of 11-NOV-2020 (Primary Completion Date) (up to 13 months)

Secondary outcomes (5)

  1. Duration of Response (DOR)

    DOR was defined for responders only as the time from first documentation of response (i.e. CR or PR) until disease progression or death (if death without documented disease progression).

    CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of < 10 mm.

    PR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

    Measured: Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months)

  2. Disease Control Rate (DCR) at 8 and 16 Weeks

    DCR was defined as the percentage of participants with tumor response of complete response (CR), partial response (PR) or stable disease (SD).

    CR: Disappearance of all target and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have decreased in size to have a short axis of < 10 mm.

    PR: At least a 30% decrease in the sum of diameters of target lesions taking as reference the baseline sum diameters.

    SD: Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), taking as reference the smallest sum diameters while on study.

    Measured: At 8, 16, 24, 32 and 40 weeks

  3. Progression-free Survival (PFS)

    PFS was the time from first dose of study medication to disease progression or death, whichever was earlier.

    Measured: Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months)

  4. Overall Survival (OS)

    OS was defined as time from first dose of the study treatment to death. For patients who did not die, OS was censored at the last time point at which the survival status was known to be alive.

    Measured: Through last patient last visit (LPLV) at date of 28 MAR 2022 (up to 30 months)

  5. Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Different Severity Types of TEAEs Per Common Terminology Criteria for Adverse Events (CTCAE) v5

    TEAEs were started during treatment or within the post-treatment time window (30 days after last dose of regorafenib and 100 days after last dose of nivolumab.).

    TEAEs were summarized by system organ class (SOC) and preferred term, severity (based on CTCAE v5 grades). Laboratory data considered as AE were graded according to CTCAE v5.

    Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated.

    Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age-appropriate instrumental activities of daily living.

    Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living.

    Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death related to AE.

    Measured: 30 days after last dose of regorafenib and 100 days after last dose of nivolumab until study completion (up to 30 months)

Timeline

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

  1. First posted15 Oct 2019
  2. Study start14 Oct 2019
  3. Primary completion11 Nov 2020
  4. Study completion28 Mar 2022

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04126733
Sponsor's protocol ID
20975
Status last verified
Jun 2023
First submitted
11 Oct 2019
Last updated
18 Jul 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.

Publications

  • Fakih M, Raghav KPS, Chang DZ, Larson T, Cohn AL, Huyck TK, Cosgrove D, Fiorillo JA, Tam R, D'Adamo D, Sharma N, Brennan BJ, Wang YA, Coppieters S, Zebger-Gong H, Weispfenning A, Seidel H, Ploeger BA, Mueller U, Oliveira CSV, Paulson AS. Regorafenib plus nivolumab in patients with mismatch repair-proficient/microsatellite stable metastatic colorectal cancer: a single-arm, open-label, multicentre phase 2 study. EClinicalMedicine. 2023 Apr 6;58:101917. doi: 10.1016/j.eclinm.2023.101917. eCollection 2023 Apr.

    PubMed 37090438

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Regorafenib (Stivarga, BAY73-4506) and Nivolumab (Opdivo) in people with Colorectal Cancer, run by Bayer at 15 sites in United States.

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 8 inclusion and 10 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 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 14 Dec 2021). 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?

Overall Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1 Assessed by Investigator (time frame: Through database cut-off date of 11-NOV-2020 (Primary Completion Date) (up to 13 months)). 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 NCT04126733, which also lists 1 linked publication.

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 18 Jul 2023; AzTrials last refreshed its copy on 6 Nov 2026.

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