Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer
CHINOREC
Neoadjuvant CHemoradiotherapy With Sequential Ipilimumab and NivOlumab in RECtal Cancer (CHINOREC): a Prospective Randomized, Open-label, Multicenter, Phase II Clinical Trial
2 other identifiers
interventional
80
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jun 2020
Typical duration for phase_2
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 10, 2019
CompletedFirst Posted
Study publicly available on registry
October 11, 2019
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
March 15, 2024
CompletedApril 23, 2024
April 1, 2024
3.8 years
October 10, 2019
April 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of treatment-emergent adverse events (safety and tolerability)
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).
20 weeks
Secondary Outcomes (2)
Radiographic therapy response between pre-and post-neoadjuvant treatment
20 weeks
Pathologic therapy response to neoadjuvant treatment
20 weeks
Study Arms (2)
Neoadjuvant Chemoradiotherapy
OTHERNeoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days)
Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab
EXPERIMENTALNeoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) with sequential Ipilimumab (1 mg/kg IV on day 7) and Nivolumab (3 mg/kg IV on day 14, 28 and 42)
Interventions
Capecitabine tablet with fractionated radiotherapy
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johannes Laengle, MD, PhDlead
- Bristol-Myers Squibbcollaborator
Study Sites (5)
State Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria, Austria
Congregational Hospital Linz - Sisters of Mercy
Linz, 4010, Austria
Hospital of St. John of God
Vienna, 1020, Austria
Medical University of Vienna
Vienna, 1090, Austria
Hospital North - Clinic Floridsdorf
Vienna, 1210, Austria
Related Publications (1)
Laengle J, Kuehrer I, Kulu A, Kabiljo J, Ammon D, Zirnbauer R, Stift A, Herbst F, Dauser B, Monschein M, Razek P, Haegele S, Biebl M, Geinitz H, Hulla W, Kalinina P, Mullauer L, Widder J, Bittermann C, Pils D, Tamandl D, Laengle F, Schmid R, Bergmann M. Dual Immune Checkpoint Inhibition Plus Neoadjuvant Chemoradiotherapy in Rectal Cancer: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2527769. doi: 10.1001/jamanetworkopen.2025.27769.
PMID: 40844778DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bergmann, MD
Division of Visceral Surgery, Department of General Surgery, Medical University of Vienna
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Sponsor-Investigator
Study Record Dates
First Submitted
October 10, 2019
First Posted
October 11, 2019
Study Start
June 1, 2020
Primary Completion
March 15, 2024
Study Completion
March 15, 2024
Last Updated
April 23, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share