check_circleStudy Completed
Solid Tumors
Bayer Identifier:
21136
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
A trial to learn whether Regorafenib in combination with Nivolumab can improve tumor responses and how safe it is for participants with solid tumors
Trial purpose
Researchers are looking for a better way to treat people with solid tumors. Before a treatment can be approved for people to take, researchers do clinical trials to better understand its safety and how it works.
In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types
of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.
The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).
The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.
During the trial, the doctors will take pictures of the participants’ tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants’ heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.
In this trial, the researchers want to learn about regorafenib taken together with nivolumab in a small number of participants with different types
of tumors. These include tumors in the head and neck, the esophagus, the pancreas, the brain, and the biliary tract. The biliary tract includes gall bladder and bile ducts.
The trial will include about 200 participants who are at least 18 years old. All of the participants will take 90 mg of regorafenib as a tablet by mouth. The dose of regorafenib can be adjusted up to 120 mg or down to 60 mg by the doctor based on how well a participant tolerates treatment. All of the participants will receive 480 milligrams (mg) of nivolumab through a needle put into a vein (IV infusion).
The participants will take treatments in 4-week periods called cycles. They will take regorafenib once a day for 3 weeks, then stop for 1 week. In each cycle, the participants will receive nivolumab one time. These 4-week cycles will be repeated throughout the trial. The participants can take nivolumab and regorafenib until their cancer gets worse, until they have medical problems, or until they leave the trial. The longest nivolumab can be given is up to 2 years.
During the trial, the doctors will take pictures of the participants’ tumors using CT or MRI and will take blood and urine samples. The doctors will also do physical examinations and check the participants’ heart health using an electrocardiogram (ECG). They will ask questions about how the participants are feeling and if they have any medical problems.
Key Participants Requirements
Sex
AllAge
18 - N/ATrial summary
Enrollment Goal
175Trial Dates
February 2021 - March 2024Phase
Phase 2Could I Receive a placebo
NoProducts
Regorafenib+NivolumabAccepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Sarah Cannon Cancer Center | Nashville, 37203, United States |
Completed | University of Texas MD Anderson Cancer Center | Houston, 77030, United States |
Withdrawn | Oncology Associates of Oregon | Eugene, 97401, United States |
Completed | Istituto Oncologico Veneto_Padova - UOC Oncologia 1 | Padova, 35128, Italy |
Completed | ASST Grande Ospedale Metropolitano Niguarda - Oncologia Falck | Milan, 20162, Italy |
Completed | UZ Antwerpen | EDEGEM, 2650, Belgium |
Completed | Humanitas Mirasole S.p.A. - Oncologia Medica ed Ematologia | Rozzano, 20089, Italy |
Completed | AUSL di Bologna_Istituto delle Scienze Neurologiche - UO Oncologia del Sistema Nervoso | Bologna, 40139, Italy |
Completed | CHU de Liège | LIEGE, 4000, Belgium |
Withdrawn | Massachusetts General Hospital | Boston, 02114-2696, United States |
Completed | Hôpital Erasme/Erasmus Ziekenhuis | Brussels, 1070, Belgium |
Completed | IRCCS Foundation Istituto Neurologico Carlo Besta | Milano, 20133, Italy |
Completed | Seoul National University Hospital | Seoul, 3080, Korea,_republic_of |
Completed | Severance Hospital, Yonsei University Health System | Seoul, 03722, Korea,_republic_of |
Withdrawn | Henry Ford Health System | Detroit, 48202, United States |
Withdrawn | Dana-Farber Cancer Institute | Boston, 02215, United States |
Completed | Rocky Mountain Cancer Centers / Aurora, CO | Aurora, 80012, United States |
Completed | City of Hope - Duarte Cancer Center | Duarte, 91010, United States |
Completed | Taipei Veterans General Hospital | Taipei, 11217, Taiwan |
Completed | Moffitt Cancer Center | Tampa, 33612, United States |
Withdrawn | Tohoku University Hospital | Sendai, 980-8574, Japan |
Completed | Saitama Cancer Center | Kitaadachi-gun, 362-0806, Japan |
Completed | National Cancer Center Hospital | Chuo-ku, 104-0045, Japan |
Completed | The Cancer Institute Hospital of JFCR | Koto-ku, 135-8550, Japan |
Completed | Aichi Cancer Center Hospital | Nagoya, 464-8681, Japan |
Completed | Kobe University Hospital | Kobe, 650-0017, Japan |
Completed | China Medical University Hospital | Taichung, 404327, Taiwan |
Completed | Chi Mei Medical Center | Taikang, 71004, Taiwan |
Completed | Institut Claudius Regaud - iUCT Oncopole | TOULOUSE CEDEX 9, 31059, France |
Completed | Institut Bergonie - Unicancer Nouvelle Aquitaine | BORDEAUX CEDEX, 33076, France |
Completed | Gustave Roussy - Departement Oncologie-Radiotherapie | VILLEJUIF CEDEX, 94805, France |
Completed | Baylor Charles A. Sammons Cancer Center at Dallas | Dallas, 75246, United States |
Completed | UNICANCER - Centre Leon Berard (CLB) | lyon, 69008, France |
Completed | The Royal Marsden NHS Foundation Trust | The Royal Marden Hospital - The Royal Marsden Clinical Trials Unit (CTU) | London, SW3 6JJ, United Kingdom |
Completed | Beatson West of Scotland Cancer Centre | Glasgow, G12 0YN, United Kingdom |
Completed | University Hospitals Coventry and Warwickshire NHS Trust | Coventry, CV2 2DX, United Kingdom |
Completed | Royal Marsden NHS Trust (Surrey) | Sutton, SM2 5PT, United Kingdom |
Completed | Institut de Cancerologie Ouest - Saint-Herblain | Saint-Herblain, 44800, France |
Completed | APHP-Hopital la Pitie Salpetriere | PARIS, 75651, France |
Primary Outcome
- Overall response rate (ORR)Tumor response was evaluated as ORR per RECIST 1.1 by local assessments for all tumor types, except for GBM/AA, where ORR per RANO by local assessment was used. ORR was defined as the proportion of participants with best overall response of complete response (CR) or partial response (PR). Participants for whom best overall tumor response was not CR or PR, as well as participants without any post-baseline tumor assessment were considered non-responders. Descriptive statistics were done, no inferential statistical analyses were performed.date_rangeTime Frame:From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months
Secondary Outcome
- Duration of response (DOR)Defined as the time (in days) from the first documented objective response of PR or CR, whichever is noted earlier, to disease progression or death (if death occurs before progression is documented). DOR will be defined for responders only, i.e. participants with a CR or PR.date_rangeTime Frame:From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months
- Disease control rate (DCR)CR = Complete response; PR = Partial response; SD = Stable diseasedate_rangeTime Frame:From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months
- Progression free survival (PFS)PFS was defined as the time (in days) from the start of study intervention to the date of first objectively documented progressive disease (PD) or death from any cause (if no progression was documented).date_rangeTime Frame:From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months
- 6 months PFS6 Months PFS ratedate_rangeTime Frame:Up to last participant follow 6 months (approximately 22 months)
- Overall survival (OS)OS was defined as the time (in days) from the start of study intervention to the date of death due to any cause.date_rangeTime Frame:From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 months
- 1 year OSdate_rangeTime Frame:From first participant enrolled to cut-off date (ie after the last participant has been followed for approximately 10 months) approximately 26 month]
- Number of participants with adverse eventsAEs were considered to be treatment-emergent (TEAEs) if they started or worsened after the start of first study drug administration until 30 days after regorafenib treatment discontinuation or 100 days after the last dose of nivolumab, whatever occurred later.date_rangeTime Frame:Up to the last participant has been followed for approximately 10 months, summed up to approximately 26 months
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
TreatmentAllocation
N/ABlinding
N/AAssignment
Single Group AssignmentTrial Arms
1