Rectal CancerPhase 2CHINORECNCT04124601
Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer
A Phase 2 study testing Chemoradiotherapy, Ipilimumab and Nivolumab in people with Rectal Cancer, run by Johannes Laengle, MD, PhD at 5 sites in Austria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Chemoradiotherapy, Ipilimumab and Nivolumab
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 5 sitesAustria
- Study dates
- 1 Jun 2020to 15 Mar 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 28Show fewer
- 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 exclusion criteria: Prisoners or participants who are involuntarily incarcerated, participants who are compulsorily detained for treatment of either a psychiatric or physical (i.e. infectious disease) illness
- White blood cells < 2000/μL (SI: < 2.00 × 109/L)
- Neutrophils < 1500/μL (SI: < 1.50 × 109/L)
- Platelets < 100 × 103/μL (SI: < 100 × 109/L) (transfusions not permitted within 72 h prior to qualifying laboratory value)
- Hemoglobin < 9.0 g/dl (SI: < 90 g/L) (transfusions not permitted within 72 h prior to qualifying laboratory value)
- Serum creatinine > 1.5 × upper limit of normal (ULN) or calculated creatinine clearance < 50 ml/min (using the Cockcroft-Gault formula)
- AST/ALT: > 3.0 × ULN
- Total bilirubin > 1.5 × ULN (except participants with Gilbert Syndrome who must have a total bilirubin level of < 3.0 × ULN)
- Troponin T (TnT) or I (TnI) > 2 × institutional ULN. TnT or TnI levels between > 1 to 2 × ULN will be permitted to participate in the study if a repeat assessment remains 2 × ULN and participant undergoes a cardiac evaluation. When repeat levels within 24 h are not available, a repeat test should be conducted as soon as possible.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Austria5 sites
Congregational Hospital Linz - Sisters of Mercy
Linz, 4010
Hospital of St. John of God
Vienna, 1020
Medical University of Vienna
Vienna, 1090
Hospital North - Clinic Floridsdorf
Vienna, 1210
State Hospital Wiener Neustadt
Wiener Neustadt, Lower Austria
About this study
Official title: Neoadjuvant CHemoradiotherapy With Sequential Ipilimumab and NivOlumab in RECtal Cancer (CHINOREC): a Prospective Randomized, Open-label, Multicenter, Phase II Clinical Trial
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.
- Conditions
- Rectal Cancer
- Being tested
- Chemoradiotherapy, Ipilimumab, Nivolumab
- Keywords
- Ipilimumab, Nivolumab, Chemoradiotherapy, Rectal cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChemoradiotherapyRadiation
Also called Radiochemotherapy, Chemoradiation
Capecitabine tablet with fractionated radiotherapy
IpilimumabDrug
Also called Yervoy®
Infusion
NivolumabDrug
Also called Opdivo®
Infusion
| Study group | Role | What they receive |
|---|---|---|
| Neoadjuvant Chemoradiotherapy | Other | Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) Receives: Radiation: Chemoradiotherapy |
| Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab | Experimental | Neoadjuvant 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) Receives: Radiation: Chemoradiotherapy; Drug: Ipilimumab; Drug: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 20 weeks
Secondary outcomes (2)
Radiographic therapy response between pre-and post-neoadjuvant treatment
Radiographic therapy response will be determined by magnetic resonance imaging-assessed tumor regression grade (mrTRG)
Measured: 20 weeks
Pathologic therapy response to neoadjuvant treatment
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).
Measured: 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start1 Jun 2020
- Primary completion15 Mar 2024
- Study completion15 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Laengle, MD, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor-investigator, Johannes Laengle, MD, PhD, Medical University of Vienna
- Investigators
- Michael Bergmann, MD, Principal investigator, Division of Visceral Surgery, Department of General Surgery, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124601
- Sponsor's protocol ID
- CA209-7HJ
- Other IDs
- 2019-003865-17, 2019
- Acronym
- CHINOREC
- Status last verified
- Apr 2024
- First submitted
- 10 Oct 2019
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40844778
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neoadjuvant CHemoradiotherapy With Sequential Ipilimumab and NivOlumab in RECtal Cancer (CHINOREC): a Prospective Randomized, Open-label, Multicenter, Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04124601
- Acronym / sponsor ID
- CHINOREC / CA209-7HJ
- Conditions
- Rectal Cancer
- Keywords
- Ipilimumab, Nivolumab, Chemoradiotherapy, Rectal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Johannes Laengle, MD, PhDUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 15 Mar 2024 (actual)
- Study completion
- 15 Mar 2024 (actual)
- First posted
- 11 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Neoadjuvant Chemoradiotherapy | Other | Radiation: ChemoradiotherapyNeoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days) |
| Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab | Experimental | Radiation: Chemoradiotherapy, Drug: Ipilimumab, Drug: NivolumabNeoadjuvant 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) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ChemoradiotherapyAlso: Radiochemotherapy, ChemoradiationCapecitabine tablet with fractionated radiotherapy | Radiation | Neoadjuvant Chemoradiotherapy, Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab |
| IpilimumabAlso: Yervoy®Infusion | Drug | Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab |
| NivolumabAlso: Opdivo®Infusion | Drug | Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab |
Primary outcome
Incidence of treatment-emergent adverse events (safety and tolerability)
Time frame: 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).
2 secondary outcomes
Radiographic therapy response between pre-and post-neoadjuvant treatment
Time frame: 20 weeks
Pathologic therapy response to neoadjuvant treatment
Time frame: 20 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Derived from this study: PubMed 40844778Laengle 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Bergmann, MD principal investigator
Division of Visceral Surgery, Department of General Surgery, Medical University of Vienna
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Chemoradiotherapy, Ipilimumab and Nivolumab in people with Rectal Cancer, run by Johannes Laengle, MD, PhD at 5 sites in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-emergent adverse events (safety and tolerability) (time frame: 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04124601, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.