Neoadjuvant Chemoradiotherapy With Sequential Ipilimumab and Nivolumab in Rectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-01

Study Completion Date

2024-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Rectal Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Neoadjuvant Chemoradiotherapy

Neoadjuvant Chemoradiotherapy (50 Gy in 2 Gy fractions + Capecitabine 1650 mg/m2/d over 25 working days)

Group Type OTHER

Chemoradiotherapy

Intervention Type RADIATION

Capecitabine tablet with fractionated radiotherapy

Neoadjuvant Chemoradiotherapy, Ipilimumab, Nivolumab

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)

Group Type EXPERIMENTAL

Chemoradiotherapy

Intervention Type RADIATION

Capecitabine tablet with fractionated radiotherapy

Ipilimumab

Intervention Type DRUG

Infusion

Nivolumab

Intervention Type DRUG

Infusion

Interventions

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Chemoradiotherapy

Capecitabine tablet with fractionated radiotherapy

Intervention Type RADIATION

Ipilimumab

Infusion

Intervention Type DRUG

Nivolumab

Infusion

Intervention Type DRUG

Other Intervention Names

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Radiochemotherapy Chemoradiation Yervoy® Opdivo®

Eligibility Criteria

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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)
* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No