Colorectal CancerPhase 2NIVACORNCT04072198
Nivolumab Plus FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced Colorectal Cancer RASm/BRAFm Patients
A Phase 2 study testing Nivolumab, Bevacizumab and Irinotecan in people with Colorectal Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 8 sites in Italy.
Trial summary
This is a multicentric single arm, open label trial. In this study patients candidated to a first line of chemotherapy for metastatic colorectal cancer will be treated with 8 cycles of folfoxiri plus bevacizumab plus nivolumab followed by a maintenance with bevacizumab plus nivolumab. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Nivolumab, Bevacizumab and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 8 sitesItaly
- Study dates
- 26 Sep 2019to 30 Oct 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Male or female of 18-75 years of age on day of signing informed consent.
- Histologically confirmed diagnosis of colorectal cancer RAS/BRAF mutated.
- Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
- Patients suitable for first line chemotherapy.
- Life expectancy > 3 months.
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- At least one site of measurable disease per RECIST criteria.
- Performance status of 0-1 on the ECOG Performance Scale.
- Adequate organ function
- Availability at baseline of a representative formalin-fixed, paraffin-embedded (FFPE) diagnostic tumor specimen, as primary and/or metastatic tumor tissue block or as fifteen 5-micron unstained slides are allowed (the neoplastic cell content of each tumor sample will be assessed and in those cases with neoplastic cells <50% a macro-dissection of the specimen will be performed, if possible).
- If DPD status is known it must be wild type. No restriction are applied if DPD status in unknown.
- Women of childbearing potential must have a negative blood pregnancy test within 24 hr prior to the start of study drug. For this trial, women of childbearing potential are defined as all women after puberty, unless they are postmenopausal for at least 12 months, are surgically sterile, or are sexually inactive.
- Subjects and their partners must be willing to avoid pregnancy during the trial and until 5 months for WOCBP (Women of Childbearing Potential) and 7 months for male subjects with female partners of WOCBP after the last trial treatment. Male subjects with female partners of childbearing potential and female subjects of childbearing potential must, therefore, be willing to use adequate contraception as approved by the investigator (barriers contraceptive measure or oral contraception).
Who cannot join
- Prior chemotherapy, excluded patient treated in neo/adjuvant setting at least 12 months before diagnosis of metastatic disease.
- Radiotherapy to any site within 4 weeks before the study.
- Serious, non-healing wound, ulcer, or bone fracture.
- Evidence of bleeding diathesis or coagulopathy.
- Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
- Systemic corticosteroids within 2 weeks of the first dose of nivolumab.
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- Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 14 days prior to the first dose of trial treatment.
- Additional malignancy in the last 5 years. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
- Active and untreated brain (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are not using steroids for at least 7 days prior to trial treatment.
- Any active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids (> 10 mg daily prednisone equivalent) or immunosuppressive medications except for syndromes which would not be expected to recur in the absence of an external trigger.
- Evidence of interstitial lung disease, active non-infectious pneumonitis, or a history of grade 3 or greater pneumonitis.
- Active infection requiring systemic therapy.
- History of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
- Any positive test for hepatitis B or hepatitis C virus indicating acute or chronic infection.
- Live vaccine within 30 days prior to the first dose of trial treatment.
- Chronic, daily treatment with high-dose aspirin (>325 mg/day).
- Significant vascular disease (e.g. aortic aneurysm requiring surgical repair or recent arterial thrombosis) within 6 months of study enrolment.
- Any previous venous thromboembolism > NCI CTCAE Grade 3.
- History of abdominal fistula, GI perforation, intra-abdominal abscess or active GI bleeding within 6 months prior to the first study treatment.
- Current or recent (within 10 days prior to study treatment start) ongoing treatment with anticoagulants for therapeutic purposes.
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to study treatment start, or anticipation of the need for major surgical procedure during the course of the study.
- Presence of colic prosthesis or stent.
- History of any severe hypersensitivity reactions to any monoclonal antibody.
- Women of childbearing potential who are pregnant or breastfeeding.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Italy8 sites
Istituto Ospedaliero Fondazione Poliambulanza
Brescia
Arnas Garibaldi
Catania
Azienda Ospedaliero-Universitaria Careggi
Florence
Istituto Nazionale Tumori Fondazione G.Pascale
Naples
Istituto Oncologico Veneto
Padova
AUSL/IRCCS di Reggio Emilia
Reggio Emilia
Policlinico Universitario Campus Bio-Medico
Roma
IRCCS - Casa Sollievo della Sofferenza
San Giovanni Rotondo
About this study
Official title: Phase II Study on NIVolumab in Combination With FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced COloRectal Cancer RASm/BRAFm Patients
This is a multicentric single arm, open label trial. In this study patients candidated to a first line of chemotherapy for metastatic colorectal cancer will be treated with 8 cycles of folfoxiri plus bevacizumab plus nivolumab followed by a maintenance with bevacizumab plus nivolumab.
Patients who do not progress during chemotherapy phase will receive bevacizumab plus nivolumab as maintenance therapy.
Patients will be treated until disease progression, unacceptable toxicity or patient/physician decision.
Read the detailed description
This is a prospective, open-label, multicentric phase II trial in which patients with metastatic colorectal cancer RASm/BRAFm patients will receive nivolumab in combination with FOLFOXIRI/Bevacizumab as first line chemotherapy.
Study screening will take place within 28 days prior to initiation of study treatment. At screening, every patient must have local RAS/BRAF known status. A centralized review of RAS/BRAF status will be performed during the study.
Eligible patients will be enrolled and begin treatment with FOLFOXIRI/bevacizumab plus nivolumab every 2 weeks for 8 cycles followed by maintenance with bevacizumab plus nivolumab every 2 weeks until disease progression, unacceptable toxicity or patient/physician decision. Bevacizumab will be administered intravenously at dose of 5 mg/kg every 2 weeks. Nivolumab will be administered intravenously at flat dose of 240 mg every 2 weeks.
Folfoxiri will be administered as 165 mg/m2 intravenous infusion of irinotecan for 60 min, followed by an 85 mg/m2 intravenous infusion of oxaliplatin given concurrently with leucovorin at a dose of 200 mg/m2 for 120 min, followed by a 3200 mg/m2 continuous infusion of fluorouracil for 48 h.
During the study treatment period, patients will be followed for safety based on AE assessments including vital signs, physical findings and clinical laboratory test results.
In order to guarantee the safety of the patients, the enrolment will be stopped when the 10th patient will start treatment. An Independent Monitoring Committee will evaluate the safety data of these patients and will decide if the study should be completed, amended or closed.
Efficacy will be evaluated by the investigator according to RECIST v1.1 every 8 weeks during treatment and then every 3 months for 3 years.
During the study baseline tumor blocks will be centrally analysed to determinate inflammatory infiltrate, MSI/MSS and PD-L1 status. The biological characterization and Tumor Mutation Burden (TMB) will be also analysed centrally.
Following discontinuation of study treatment, safety assessments will be conducted 30 days after the last study drug administration or until initiation of other anti-cancer therapy (whichever occurs first). Thereafter, patients will be followed for disease progression (unless this has already occurred), SAEs, anticancer therapy and survival. Follow-up will continue for up to 3 years.
A blood sample will be collected for all patients at baseline, prior to cycle 5, at the end of chemotherapy and at disease progression.
Quality of life will be assessed at baseline, every 4 weeks during treatment and study discontinuation visit.
- Conditions
- Colorectal Cancer
- Being tested
- Nivolumab, Bevacizumab, Irinotecan, Oxaliplatin, Leucovorin
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NivolumabDrug
240 mg every 2 weeks for 8 cycles followed by maintenance
BevacizumabDrug
5 mg/kg every 2 weeks for 8 cycles followed by maintenance
IrinotecanDrug
165 mg/m2 every 2 weeks for 8 cycles
OxaliplatinDrug
85 mg/m2 every 2 weeks for 8 cycles
LeucovorinDrug
200 mg/m2 every 2 weeks for 8 cycles
fluoruracilDrug
3200mg/m2 every 2 weeks for 8 cycles
| Study group | Role | What they receive |
|---|---|---|
| FOLFOXIRI/Bevacizumab + Nivolumab | Experimental | Bevacizumab 5 mg/m2 Nivolumab 240 mg Irinotecan 165 mg/m2 iv (max 8 cycles) Oxaliplatin + leucovorin 200 mg/m2 (max 8 cycles) Fluorouracil 3200 mg/m2 (max 8 cycles) Receives: Drug: Nivolumab; Drug: Bevacizumab; Drug: Irinotecan; Drug: Oxaliplatin; Drug: Leucovorin; Drug: fluoruracil |
What is being measured
The primary outcome is the main question the study is designed to answer.
ORR
To demonstrate that adding nivolumab to standard colorectal first line chemotherapy improves the Overall Response Rate as determinated using RECIST 1.1 criteria
Measured: 36 months
Secondary outcomes (5)
Safety of combination
Safety assessments will include the incidence, nature, and severity of Adverse Events (AEs)
Measured: 36 months
OS
Evaluate the efficacy in terms of overall survival (OS) defined as the time from start of study drug to the date of death from any cause
Measured: 36 months
TTP
To evaluate the Time To Progression (TTP) defined as the time between the date of start of study drug and the first date of documented progression, based on investigator assessment (as per RECIST 1.1 criteria), or death due to any cause, whichever occurs first
Measured: 36 months
Duration of response
To evaluate the duration of response defined as the time between the date of first evidence of response (SD/PR/CR) and the date of documented progression or death due to any cause, whichever occurs first
Measured: 36 months
Quality of life with QLQ-C30 questionnaire
To evaluate the quality of life of patients determinated with questionnaire
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start26 Sep 2019
- Primary completion30 Aug 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca Clinica
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmine Pinto, MD, Principal investigator, Gruppo Oncologico Italiano di Ricerca Clinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04072198
- Sponsor's protocol ID
- GOIRC-03-2018
- Acronym
- NIVACOR
- Status last verified
- Mar 2025
- First submitted
- 22 Aug 2019
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Damato A, Bergamo F, Antonuzzo L, Nasti G, Iachetta F, Romagnani A, Gervasi E, Larocca M, Pinto C. FOLFOXIRI/Bevacizumab Plus Nivolumab as First-Line Treatment in Metastatic Colorectal Cancer RAS/BRAF Mutated: Safety Run-In of Phase II NIVACOR Trial. Front Oncol. 2021 Dec 14;11:766500. doi: 10.3389/fonc.2021.766500. eCollection 2021.
PubMed 34970487Damato A, Iachetta F, Antonuzzo L, Nasti G, Bergamo F, Bordonaro R, Maiello E, Zaniboni A, Tonini G, Romagnani A, Berselli A, Normanno N, Pinto C. Phase II study on first-line treatment of NIVolumab in combination with folfoxiri/bevacizumab in patients with Advanced COloRectal cancer RAS or BRAF mutated - NIVACOR trial (GOIRC-03-2018). BMC Cancer. 2020 Aug 31;20(1):822. doi: 10.1186/s12885-020-07268-4.
PubMed 32867715
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study on NIVolumab in Combination With FOLFOXIRI/Bevacizumab in First Line Chemotherapy of Advanced COloRectal Cancer RASm/BRAFm Patients
- ClinicalTrials.gov ID
- NCT04072198
- Acronym / sponsor ID
- NIVACOR / GOIRC-03-2018
- Conditions
- Colorectal Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Gruppo Oncologico Italiano di Ricerca ClinicaUniversity, hospital or other
- Study start
- 26 Sep 2019 (actual)
- Primary completion
- 30 Aug 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 28 Aug 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 is a multicentric single arm, open label trial. In this study patients candidated to a first line of chemotherapy for metastatic colorectal cancer will be treated with 8 cycles of folfoxiri plus bevacizumab plus nivolumab followed by a maintenance with bevacizumab plus nivolumab.
Patients who do not progress during chemotherapy phase will receive bevacizumab plus nivolumab as maintenance therapy.
Patients will be treated until disease progression, unacceptable toxicity or patient/physician decision.
Detailed description
This is a prospective, open-label, multicentric phase II trial in which patients with metastatic colorectal cancer RASm/BRAFm patients will receive nivolumab in combination with FOLFOXIRI/Bevacizumab as first line chemotherapy.
Study screening will take place within 28 days prior to initiation of study treatment. At screening, every patient must have local RAS/BRAF known status. A centralized review of RAS/BRAF status will be performed during the study.
Eligible patients will be enrolled and begin treatment with FOLFOXIRI/bevacizumab plus nivolumab every 2 weeks for 8 cycles followed by maintenance with bevacizumab plus nivolumab every 2 weeks until disease progression, unacceptable toxicity or patient/physician decision. Bevacizumab will be administered intravenously at dose of 5 mg/kg every 2 weeks. Nivolumab will be administered intravenously at flat dose of 240 mg every 2 weeks.
Folfoxiri will be administered as 165 mg/m2 intravenous infusion of irinotecan for 60 min, followed by an 85 mg/m2 intravenous infusion of oxaliplatin given concurrently with leucovorin at a dose of 200 mg/m2 for 120 min, followed by a 3200 mg/m2 continuous infusion of fluorouracil for 48 h.
During the study treatment period, patients will be followed for safety based on AE assessments including vital signs, physical findings and clinical laboratory test results.
In order to guarantee the safety of the patients, the enrolment will be stopped when the 10th patient will start treatment. An Independent Monitoring Committee will evaluate the safety data of these patients and will decide if the study should be completed, amended or closed.
Efficacy will be evaluated by the investigator according to RECIST v1.1 every 8 weeks during treatment and then every 3 months for 3 years.
During the study baseline tumor blocks will be centrally analysed to determinate inflammatory infiltrate, MSI/MSS and PD-L1 status. The biological characterization and Tumor Mutation Burden (TMB) will be also analysed centrally.
Following discontinuation of study treatment, safety assessments will be conducted 30 days after the last study drug administration or until initiation of other anti-cancer therapy (whichever occurs first). Thereafter, patients will be followed for disease progression (unless this has already occurred), SAEs, anticancer therapy and survival. Follow-up will continue for up to 3 years.
A blood sample will be collected for all patients at baseline, prior to cycle 5, at the end of chemotherapy and at disease progression.
Quality of life will be assessed at baseline, every 4 weeks during treatment and study discontinuation visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FOLFOXIRI/Bevacizumab + Nivolumab | Experimental | Drug: Nivolumab, Drug: Bevacizumab, Drug: Irinotecan, Drug: Oxaliplatin, Drug: Leucovorin, Drug: fluoruracilBevacizumab 5 mg/m2 Nivolumab 240 mg Irinotecan 165 mg/m2 iv (max 8 cycles) Oxaliplatin + leucovorin 200 mg/m2 (max 8 cycles) Fluorouracil 3200 mg/m2 (max 8 cycles) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Written informed consent.
- Male or female of 18-75 years of age on day of signing informed consent.
- Histologically confirmed diagnosis of colorectal cancer RAS/BRAF mutated.
- Initially unresectable metastatic colorectal cancer not previously treated with chemotherapy for metastatic disease.
- Patients suitable for first line chemotherapy.
Key exclusion criteria (24 listed)
- Prior chemotherapy, excluded patient treated in neo/adjuvant setting at least 12 months before diagnosis of metastatic disease.
- Radiotherapy to any site within 4 weeks before the study.
- Serious, non-healing wound, ulcer, or bone fracture.
- Evidence of bleeding diathesis or coagulopathy.
- Uncontrolled hypertension and prior history of hypertensive crisis or hypertensive encephalopathy.
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 |
|---|---|---|
| Nivolumab240 mg every 2 weeks for 8 cycles followed by maintenance | Drug | FOLFOXIRI/Bevacizumab + Nivolumab |
| Bevacizumab5 mg/kg every 2 weeks for 8 cycles followed by maintenance | Drug | FOLFOXIRI/Bevacizumab + Nivolumab |
| Irinotecan165 mg/m2 every 2 weeks for 8 cycles | Drug | FOLFOXIRI/Bevacizumab + Nivolumab |
| Oxaliplatin85 mg/m2 every 2 weeks for 8 cycles | Drug | FOLFOXIRI/Bevacizumab + Nivolumab |
| Leucovorin200 mg/m2 every 2 weeks for 8 cycles | Drug | FOLFOXIRI/Bevacizumab + Nivolumab |
| fluoruracil3200mg/m2 every 2 weeks for 8 cycles | Drug | FOLFOXIRI/Bevacizumab + Nivolumab |
Primary outcome
ORR
Time frame: 36 months
To demonstrate that adding nivolumab to standard colorectal first line chemotherapy improves the Overall Response Rate as determinated using RECIST 1.1 criteria
5 secondary outcomes
Safety of combination
Time frame: 36 months
OS
Time frame: 36 months
TTP
Time frame: 36 months
Duration of response
Time frame: 36 months
Quality of life with QLQ-C30 questionnaire
Time frame: 36 months
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 13 Mar 2025.
- Derived from this study: PubMed 34970487Damato A, Bergamo F, Antonuzzo L, Nasti G, Iachetta F, Romagnani A, Gervasi E, Larocca M, Pinto C. FOLFOXIRI/Bevacizumab Plus Nivolumab as First-Line Treatment in Metastatic Colorectal Cancer RAS/BRAF Mutated: Safety Run-In of Phase II NIVACOR Trial. Front Oncol. 2021 Dec 14;11:766500. doi: 10.3389/fonc.2021.766500. eCollection 2021.
- Derived from this study: PubMed 32867715Damato A, Iachetta F, Antonuzzo L, Nasti G, Bergamo F, Bordonaro R, Maiello E, Zaniboni A, Tonini G, Romagnani A, Berselli A, Normanno N, Pinto C. Phase II study on first-line treatment of NIVolumab in combination with folfoxiri/bevacizumab in patients with Advanced COloRectal cancer RAS or BRAF mutated - NIVACOR trial (GOIRC-03-2018). BMC Cancer. 2020 Aug 31;20(1):822. doi: 10.1186/s12885-020-07268-4.
- 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.
Carmine Pinto, MD principal investigator
Gruppo Oncologico Italiano di Ricerca Clinica
8 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 Nivolumab, Bevacizumab and Irinotecan in people with Colorectal Cancer, run by Gruppo Oncologico Italiano di Ricerca Clinica at 8 sites in Italy.
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 13 inclusion and 24 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 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Italy. 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?
ORR (time frame: 36 months). 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 NCT04072198, which also lists 2 linked publications.
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 13 Mar 2025.