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A phase II trial of neoadjuvant REGorafenib in combination with nIvolumab and short-course radiotherapy iN intermediate-risk, stage II-III rectAl cancer
EU CTIS ID: 2024-516554-22-00
What this study is testing
To demonstrate that administering combination treatment with nivolumab plus regorafenib before and after standard, pre-operative SCRT is associated with a promising complete response (CR) rate in subjects with pMMR/MSS tumours.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female or Male
- Adequate renal function as defined by an estimated creatinine clearance ≥30 mL/min according to the Cockcroft-Gault or Wright formula
- Negative serum pregnancy test at screening (up to 7 days before treatment start) for women of childbearing potential
- treatment start) for women of childbearing potential 12) Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatment.
- Men with childbearing potential partner must agree to use condom during the course of this study and for at least 5 months after the last administration of the study treatment.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
You likely can't join if
- Any prior or concurrent surgery, chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for rectal cancer. Concurrent use of hormones for noncancer-related conditions (i.e., insulin for diabetes and hormone replacement therapy) is acceptable.
- Prior myocarditis
- Known history of immune colitis, immune pneumonitis, pulmonary fibrosis or other medical conditions (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject’s tolerance of trial treatment
- Vaccination within 28 days of the first dose of study treatment and while on trial (except for administration of inactivated vaccines)
- Other invasive malignancy within 2 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. Anti-neoplastic treatment received in the past for malignancies cured 2 or more years before enrolment are permitted.
- Any investigational anti-cancer therapy other than the protocol specified therapies.
See the full eligibility criteria
Who can join
- Female or Male
- Adequate renal function as defined by an estimated creatinine clearance ≥30 mL/min according to the Cockcroft-Gault or Wright formula
- Negative serum pregnancy test at screening (up to 7 days before treatment start) for women of childbearing potential
- treatment start) for women of childbearing potential 12) Women of childbearing potential must agree to use of one highly effective method of contraception prior study entry, during the course of the study and at least 7 months after the last administration of study treatment.
- Men with childbearing potential partner must agree to use condom during the course of this study and for at least 5 months after the last administration of the study treatment.
- Absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- Absence of clinical conditions that, in the opinion of the investigator, would contraindicate neoadjuvant therapy and/or surgery
- Life expectancy of at least 3 months
- Completion of all necessary screening procedures within 28 days prior to enrolment.
- Signed Informed Consent form (ICF) obtained prior to any study related procedure.
- Age ≥ 18 years old
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
- Histologically or cytologically verified adenocarcinoma of the rectum
- Tumour with distal border below the peritoneal reflection and within 15 cm from the anal verge
- Stage cT3/T4a and Nany or cT1-2 and N+ as documented by baseline pelvic MRI
- Absence of distant metastases as shown by baseline computed tomography (CT) of the thorax-abdomen or CT scan of the thorax and MRI of the abdomen
- Adequate haematological function as defined by absolute neutrophil count (ANC) ≥1.5 × 109/L, platelet count ≥100 × 109/L, and haemoglobin ≥9 g/dL
- Adequate hepatic function as defined by a total bilirubin level ≤1.5 × the upper limit of normal (ULN) range (excluding subjects with known Gilbert’s syndrome), and alanine aminotransferase (ALT) levels ≤2.5 × ULN
What rules you out
- Any prior or concurrent surgery, chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for rectal cancer. Concurrent use of hormones for noncancer-related conditions (i.e., insulin for diabetes and hormone replacement therapy) is acceptable.
- Prior myocarditis
- Known history of immune colitis, immune pneumonitis, pulmonary fibrosis or other medical conditions (for example, inflammatory bowel disease, uncontrolled asthma), which, in the opinion of the Investigator, might impair the subject’s tolerance of trial treatment
- Vaccination within 28 days of the first dose of study treatment and while on trial (except for administration of inactivated vaccines)
- Other invasive malignancy within 2 years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. Anti-neoplastic treatment received in the past for malignancies cured 2 or more years before enrolment are permitted.
- Any investigational anti-cancer therapy other than the protocol specified therapies.
- therapies. 15) Strong inhibitors of CYP3A4 activity (e.g. clarithromycin, grapefruit juice, itraconazole, ketoconazole, posaconazole, telithromycin and voriconazole), strong UGT1A9 inhibitors (e.g. mefenamic acid, diflunisal, and niflumic acid), and strong inducers of CYP3A4 (e.g. rifampicin, phenytoin, carbamazepine, phenobarbital and St. John’s wort) from 28 days before study enrolment up to the end of study treatment.
- Major surgery within 28 days of the first dose of study treatment
- Presence of gastrointestinal perforation or fistula
- Any contraindication to pelvic irradiation as evaluated by the investigator
- Prior organ transplantation, including allogeneic stem cell transplantation
- Clinically significant acute or chronic infections including, among others: - known history of testing positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS) - known history of testing positive for hepatitis B virus (HBV) surface antigen or anti-hepatitis C virus (HCV) antibody and confirmatory HCV ribonucleic acid (RNA) test
- Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent (subjects with diabetes type I, vitiligo, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible)
- Systemic corticosteroids administered as hormone replacement or as immunosuppressants at doses exceeding 10 mg/day of prednisone or equivalent. Other immunosuppressive medications including, but not limited to methotrexate, azathioprine, and TNF-α blockers. Use of immunosuppressive medications for the management of treatmentrelated AEs or in subjects with contrast allergies is acceptable. A temporary period of steroids is allowed for different indications, at the discretion of the investigator (i.e., chronic obstructive pulmonary disease, radiation, nausea, etc.). Administration of steroids through a route known to result in a minimal systemic exposure [topical, intranasal, intro-ocular, or inhalation] is acceptable
- Known severe hypersensitivity reactions to the investigational treatments, or any excipients or non-investigational medicinal products or concomitant medications
- Pregnant and/or lactating women
- Clinically significant (i.e., active) cardiovascular disease: cerebral vascular accident/stroke, myocardial infarction, unstable angina, congestive heart failure, uncontrolled arterial hypertension, or serious cardiac arrhythmia requiring medication
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.