Rectal Cancer
Conditions
Keywords
Ipilimumab, Nivolumab, Chemoradiotherapy, Rectal cancer
Brief summary
This prospective randomized, open-label, multicenter, phase II clinical trial investigates the safety and tolerability of standard neoadjuvant chemoradiotherapy (CRT) with sequential ipilimumab and nivolumab in rectal cancer.
Interventions
RADIATIONChemoradiotherapy
Capecitabine tablet with fractionated radiotherapy
DRUGIpilimumab
Infusion
DRUGNivolumab
Infusion
Sponsors
Bristol-Myers Squibb
Johannes Laengle, MD, PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * All sexes * Histologically confirmed carcinoma of the rectum * Suitable for local therapy with curative intent * Medical need for a standard neoadjuvant CRT * Suitable to withstand a course of standard neoadjuvant CRT * Written informed consent form (ICF) for participation in the study * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
Exclusion criteria
* Metastatic disease that is considered incurable by local therapies * Previous surgery of the tumor other than biopsy * Pregnancy, breastfeeding or expectancy to conceive * Disagreement of participants with reproductive potential to use contraception throughout the study period and for up to 180 days after the last dose of study therapy * Prior therapy with anti-CTLA-4, anti-PD-1, anti-PD-L1, anti-PD-L2 or any other agent directed against co-inhibitory T cell receptors or has previously participated in clinical studies with immunotherapy * Any contraindication according to the official medical information of Ipilimumab or Nivolumab * Live vaccine within 30 days prior to the first dose of study therapy * Hepatitis B or C * Human immunodeficiency virus (HIV) * Immunodeficiency * Allogeneic tissue or solid organ transplantation * Autoimmune disease that has required systemic therapy in the past 2 years with modifying agents, steroids or immunosuppressive drugs * Systemic steroids or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment * Active non-infectious pneumonitis * Active infection requiring systemic therapy * Treatment with botanical preparations (i.e. herbal supplements or traditional Chinese medicines) intended for general health support or to treat the disease under study within 2 weeks prior to randomization/treatment * Participants with serious or uncontrolled medical disorders * Uncontrolled or significant cardiovascular disease (myocardial infarction, uncontrolled angina, any history of clinically significant arrhythmias, QTc prolongation in males \> 450 ms and \> 470 ms in females, participants with history of myocarditis) * Allergies and adverse drug reaction (history of allergy or hypersensitivity to study drug components, contraindications to any of the study drugs of the chemotherapy regimen) * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of treatment-emergent adverse events (safety and tolerability) | 20 weeks | Incidence of treatment-emergent adverse events will be assessed according to the latest Clavien- Dindo Classification of surgical complications and Common Terminology Criteria of Adverse Events (CTCAE). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Radiographic therapy response between pre-and post-neoadjuvant treatment | 20 weeks | Radiographic therapy response will be determined by magnetic resonance imaging-assessed tumor regression grade (mrTRG) |
| Pathologic therapy response to neoadjuvant treatment | 20 weeks | Pathological therapy response will be determined according to the latest American Joint Committee on Cancer/International Union Against Cancer-Tumor Node Metastasis (AJCC/UICC-TNM) staging and tumor regression grade (TRG). |
Countries
Austria
Outcome results
None listed