check_circleStudy Completed

Solid Tumors

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

Trial summary

Enrollment Goal
175
Trial Dates
February 2021 - March 2024
Phase
Phase 2
Could I Receive a placebo
No
Products
Regorafenib+Nivolumab
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Sarah Cannon Cancer CenterNashville, 37203, United States
Completed
University of Texas MD Anderson Cancer CenterHouston, 77030, United States
Withdrawn
Oncology Associates of OregonEugene, 97401, United States
Completed
Istituto Oncologico Veneto_Padova - UOC Oncologia 1Padova, 35128, Italy
Completed
ASST Grande Ospedale Metropolitano Niguarda - Oncologia FalckMilan, 20162, Italy
Completed
UZ AntwerpenEDEGEM, 2650, Belgium
Completed
Humanitas Mirasole S.p.A. - Oncologia Medica ed EmatologiaRozzano, 20089, Italy
Completed
AUSL di Bologna_Istituto delle Scienze Neurologiche - UO Oncologia del Sistema NervosoBologna, 40139, Italy
Completed
CHU de LiègeLIEGE, 4000, Belgium
Withdrawn
Massachusetts General HospitalBoston, 02114-2696, United States
Completed
Hôpital Erasme/Erasmus ZiekenhuisBrussels, 1070, Belgium
Completed
IRCCS Foundation Istituto Neurologico Carlo BestaMilano, 20133, Italy
Completed
Seoul National University HospitalSeoul, 3080, Korea,_republic_of
Completed
Severance Hospital, Yonsei University Health SystemSeoul, 03722, Korea,_republic_of
Withdrawn
Henry Ford Health SystemDetroit, 48202, United States
Withdrawn
Dana-Farber Cancer InstituteBoston, 02215, United States
Completed
Rocky Mountain Cancer Centers / Aurora, COAurora, 80012, United States
Completed
City of Hope - Duarte Cancer CenterDuarte, 91010, United States
Completed
Taipei Veterans General HospitalTaipei, 11217, Taiwan
Completed
Moffitt Cancer CenterTampa, 33612, United States
Withdrawn
Tohoku University HospitalSendai, 980-8574, Japan
Completed
Saitama Cancer CenterKitaadachi-gun, 362-0806, Japan
Completed
National Cancer Center HospitalChuo-ku, 104-0045, Japan
Completed
The Cancer Institute Hospital of JFCRKoto-ku, 135-8550, Japan
Completed
Aichi Cancer Center HospitalNagoya, 464-8681, Japan
Completed
Kobe University HospitalKobe, 650-0017, Japan
Completed
China Medical University HospitalTaichung, 404327, Taiwan
Completed
Chi Mei Medical CenterTaikang, 71004, Taiwan
Completed
Institut Claudius Regaud - iUCT OncopoleTOULOUSE CEDEX 9, 31059, France
Completed
Institut Bergonie - Unicancer Nouvelle AquitaineBORDEAUX CEDEX, 33076, France
Completed
Gustave Roussy - Departement Oncologie-RadiotherapieVILLEJUIF CEDEX, 94805, France
Completed
Baylor Charles A. Sammons Cancer Center at DallasDallas, 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 CentreGlasgow, G12 0YN, United Kingdom
Completed
University Hospitals Coventry and Warwickshire NHS TrustCoventry, CV2 2DX, United Kingdom
Completed
Royal Marsden NHS Trust (Surrey)Sutton, SM2 5PT, United Kingdom
Completed
Institut de Cancerologie Ouest - Saint-HerblainSaint-Herblain, 44800, France
Completed
APHP-Hopital la Pitie SalpetrierePARIS, 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 disease
    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
  • 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 PFS
    6 Months PFS rate
    date_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 OS
    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 month]
  • Number of participants with adverse events
    AEs 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

A Multi-indication, Single-treatment Arm, Open-label Phase 2 Study of Regorafenib and Nivolumab in Combination in Patients with Recurrent or Metastatic Solid Tumors
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Treatment
Allocation
N/A
Blinding
N/A
Assignment
Single Group Assignment
Trial Arms
1