Treatment Related CancerPhase 2NCT05217069
FOLFIRI + Cetuximab + Avelumab RAS Wild-type CRC
A Phase 2 study testing 5-FU, Folinic Acid and Irinotecan in people with Treatment Related Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
Trial summary
Within the proposed single arm multicenter phase-II trial it is intended to investigate the feasi-bility of adding Avelumab to FOLFIRI plus Cetuximab after 4 cycles (2 months) of treatment with FOLFIRI plus Cetuximab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Treatment Related Cancer
- What is being tested?
- 5-FU, Folinic Acid and Irinotecan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteGermany
- Study dates
- 27 Sep 2019to 18 Oct 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed, UICC stage IV adenocarcinoma of the colon or rectum with metastases (metastatic colorectal cancer), metastases primarily non-resectable or surgery refused by the patient
- RAS wild-type tumour status (KRAS and NRAS exon 2, 3, 4) (proven in the primary tumour or metastasis)
- Age ≥18
- ECOG performance status 0-1
- Patients suitable for chemotherapy administration
- Patient's written declaration of consent obtained
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- Estimated life expectancy > 3 months
- Presence of at least one measurable reference lesion according to the RECIST 1.1 criteria
- Primary tumour tissue available and patient consents to storage and molecular and genetic profiling of tumour material. Molecular profiling of blood samples is optionally performed.
- Females of childbearing potential (FCBPs) and men must agree to use highly effec-tive contraceptive measures (Pearl index <1) or practice true abstinence from any heterosexual intercourse (true abstinence is acceptable when this is in line with the preferred and usual lifestyle of the subject) for the duration of the study treatment and for at least 6 months after last administration of study medication. A woman will be considered as being of childbearing potential unless she is at least 50 years old and moreover has gone through menopause for at least 2 years or has been surgically sterilised.
- Adequate bone marrow function:
- Leukocytes ≥ 3.0 x 109/L with neutrophils ≥ 1.5 x 109/L
- Thrombocytes ≥ 100 x 109/L
- Haemoglobin ≥ 5.6 mmol/L (equivalent to 9 g/dL)
- Adequate hepatic function:
- Serum bilirubin ≤ 1.5 x upper limit of normal (ULN)
- ALAT and ASAT ≤ 2.5 x ULN (in the presence of hepatic metastases, ALAT and ASAT ≤ 5 x ULN)
- INR < 1.5 and aPTT < 1.5 x ULN (patients without anticoagulation). Therapeu-tic anticoagulation is allowed if INR and aPTT have remained stable within the therapeutic range for at least 2 weeks.
- Adequate renal function:
- Creatinine clearance (calculated according to Cockcroft and Gault) ≥ 50 mL/min
- Adequate cardiac function: ECG and echocardiogram with a LVEF of ≥ 55%
- No previous chemotherapy for metastatic disease. Patient with need of immediate treatment (high tumour load, symptoms) may have received one application of FOLFIRI prior to study entry.
- Time interval since last administration of any previous neoadjuvant/adjuvant chemo-therapy or radiochemotherapy of the primary tumour in curative treatment intention ≥ 6 months.
- Any relevant toxicities of prior treatments must have resolved
Who cannot join
- Proof of a RAS mutation (KRAS or NRAS, exons 2, 3, 4 in the tumor (proven in the primary tumor or metastasis) or absence of testing for RAS mutation
- Primarily resectable metastases and the patient wishes for resection
- ≥ Grade II heart failure (NYHA classification)
- Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cere-bral vascular accident/stroke within the past 12 months before start of study treat-ment, unstable angina pectoris, serious cardiac arrhythmia according to investigator's judgement requiring medication.
- Pre-existing pulmonary fibrosis or immune pneumonitis
- Active autoimmune disease that might be negatively affected by an immune check-point inhibitor. Patients with diabetes type I, vitiligo, psoriasis, or hypo- or hyperthyroid diseases not requiring immunosuppressive treatment are eligible.
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- Prior organ transplantation, including allogeneic stem cell transplantation
- Current use of immunosuppressive medication, except for the following:
- Intranasal, inhaled, topical steroids, or local steroid injection (e.g., intra-articular injection);
- Systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent;
- Steroids as premedication for hypersensitivity reactions (e.g., CT scan pre-medication).
- Pregnancy (absence of pregnancy to be ascertained by a negative beta hCG test) or breast feeding
- Medical or psychological impairments associated with restricted ability to give con-sent or not allowing conduct of the study
- Additional cancer treatment (chemotherapy, radiation, immunotherapy or hormone treatment) during the study treatment in first-line and third-line treatment (treatments that are conducted as part of an anthroposophic or homeopathic treatment approach, e.g. mistletoe therapy do not represent an exclusion criterion)
- Previous chemotherapy for the colorectal cancer with the exception of adjuvant treatment, completed at least 6 months before entering the study
- Toxicity > Grade 1 that has not yet resolved, attributed to a previous treatment or measure for treatment of the mCRC. However, alopecia (all grades) and oxaliplatin-induced neurotoxicity ≤ Grade 2 are acceptable.
- Participation in a clinical study or experimental drug treatment within 30 days prior to study inclusion or within a period of 5 half-lives of the substances administered in a clinical study or during an experimental drug treatment prior to inclusion in the study, depending on which period is longest or simultaneous participation in another study while taking part in the study
- Known hypersensitivity or allergic reaction to any of the following substances: 5-fluorouracil, folinic acid, capecitabine, cetuximab, irinotecan, bevacizumab, avelumab and chemically related substances and/or hypersensitivity to any of the components in the formulations of the aforementioned substances, including known hypersensitivi-ty reactions to monoclonal antibodies NCI CTCAE Grade ≥ 3.
- Known hypersensitivity to Chinese hamster ovary cell (CHO) - cellular products or other recombinant human or humanised monoclonal antibodies
- Patients with known brain metastases. In case of clinical suspicion of brain metastasis a cranial CT or MRI must be performed to rule out brain metastasis before study in-clusion.
- History of acute or subacute intestinal occlusion, inflammatory bowel disease, im-mune colitis or chronic diarrhoea
- Symptomatic peritoneal carcinosis
- Severe, non-healing wounds, ulcers or bone fractures
- Patients with active infection requiring systemic therapy
- Known history of testing positive for HIV or known acquired immunodeficiency syn-drome.
- Active or chronic Hepatitis B virus (HBV) or hepatitis C virus (HCV) infection (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test positive; sero-logic tests required).
- Requirement for immunisation with live vaccine under the study treatment.
- Haemorrhagic diathesis or known thrombophilia
- Known DPD deficiency (specific screening not required)
- Known glucuronidation deficiency (Gilbert's syndrome) (specific screening not re-quired)
- History of a second primary malignancy during the past 5 years before inclusion in the study or during participation in the study, with the exception of a basal cell or squamous cell carcinoma of the skin or cervical carcinoma in situ, if these were treated curatively.
- Known history of alcohol or drug abuse
- Any other severe acute or chronic concomitant disease or medical condition including psychiatric conditions (including recent i.e. within the past year or active suicidal idea-tion or behavior) or laboratory abnormalities that may increase the risk associated with study participation or study treatment administration or may interfere with the in-terpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
- Absent or restricted legal capacity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Avelumab Added to FOLFIRI Plus Cetuximab Followed by Avelumab Maintenance in Patients With Previously Untreated RAS Wild-type Colorectal Cancer. The Phase II FIRE-6 Study
Within the proposed single arm multicenter phase-II trial it is intended to investigate the feasi-bility of adding Avelumab to FOLFIRI plus Cetuximab after 4 cycles (2 months) of treatment with FOLFIRI plus Cetuximab. After 4 more cycles of FOLFIRI plus Cetuximab plus Avelumab the treatment will be de-escalated to Avelumab as a maintenance concept until progression of the disease according to RECIST 1.1 has occurred.
Read the detailed description
After 4-6 months of doublet chemotherapy a de-escalation to a less toxic regimen is needed for most of the patient with mCRC. The addition of Avelumab to a cytotoxic chemotherapy regimen with FOLFIRI plus cetuximab followed by Avelumab maintenance has not been in-vestigated so far. It is known that FOLFIRI plus cetuximab leads to necrosis and therefore tumor antigens that usually are not presented to the host immune system become recogniza-ble. This effect of a triggered immune system after induction treatment with chemotherapy is currently investigated in other trials. The ongoing IMPALA trial is testing the toll-like receptor (TLR)-9 agonist MGN1703 as maintenance treatment in patients that have responded to an induction doublet chemothera-py. This effect may be enhanced by the fact that Cetuximab in Combination with 5-FU and Irinotecan triggers immunogenic cell death.
The lately published data from the interim analysis of the PACIFIC trial using the anti-PD L1 antibody durvalumab after chemoradiation in stage II non-small cell lung cancer (NSCLC) proofed the concept of an anti-PD L1 antibody as a maintenance treatment after chemoradi-ation. Durvalumab prolonged PFS significantly (HR 0.52, p<0.001).
The study is not limited to MSI-h and should be able to demonstrate Avelumab efficacy in MSS tumors. The lately presented data on the use of atezolizumab plus cobimetinib (NCT01988896) in in heavily pretreated MSS mCRC patients showed a 12-month OS rate of 43% which was higher than the 24% seen for Regorafenib in the pivotal CORECT trial. Therefore it is worthwhile to test this concept in MSS mCRC.
Furthermore part of the cetuximab effect can be attributed to ADCC (antibody derived cellu-lar cyctotoxicity) with again leads to necrosis of tumor cells and the release of antigens. Both effects together may be able to present enough tumor-neo-antigens. To boost the effect, Avelumab is able to inhibit the PD-1 derived inhibition of cytolysis and other tumor cells within the body may be attacked by the immune system which leads to an anti-tumor effect repre-sented by a prolonged PFS and finally OS of the patients.
- Conditions
- Treatment Related Cancer
- Being tested
- 5-FU, Folinic Acid, Irinotecan, Cetuximab, Avelumab
- Keywords
- CRC, Avelumab, FIRE, RAS
- Medical subject headings
- Neoplasms, Second Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5-FUDrug
400 mg/m2 (i.v. bolus) 2400 mg/m2 (i.v. 46h)
Folinic AcidDrug
400mg/m2
IrinotecanDrug
180 mg/m2
CetuximabDrug
400 mg/m2 i.v. 120min initial dose 250 mg/m2 i.v. 60min q 1w
AvelumabDrug
10mg/kg IV (day 1 q2w)
| Study group | Role | What they receive |
|---|---|---|
| RAS wild-type Avelumab | Other | Induction therapy:
FOLFIRI 5-FU: 400 mg/m2 (i.v. bolus) Folinic acid: 400mg/m2 Irinotecan: 180 mg/m2 5-FU: 2.400 mg/m2 (i.v. 46h)
Cetuximab 400 mg/m2 i.v. 120min initial dose 250 mg/m2 i.v. 60min q 1w
Maintenance therapy:
Avelumab 10mg/kg IV (day 1 q2w) Receives: Drug: 5-FU; Drug: Folinic Acid; Drug: Irinotecan; Drug: Cetuximab; Drug: Avelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival (PFS)
The primary clinical objective is to determine the efficacy of a standard 1st-line regimen (FOLFIRI plus cetuximab) in patients with RAS wild-type mCRC with Avelumab mainte-nance in terms of progression free survival rate after 8 months (according to RECIST 1.1).
Measured: up to 8 months
Secondary outcomes (3)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Determine safety and tolerability, according to NCI CTC AE v4.03 and to the obtained data on vital signs, clinical parameters (oxygen saturation) and feasibility of the regimen.
Measured: up to 36 months
Efficacy of experimental Regimen according to response rate
Determine the efficacy of the experimental regimen in terms of objective response rate (acc. to RECIST v1.1 and irRE-CIST)
Measured: up to 36 months
Efficacy of experimental Regimen according to Overall survial
Determine the efficacy of the experimental regimen in terms of overall survival.
Measured: up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start27 Sep 2019
- Primary completion1 Sep 2023
- Study completion18 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Treatment Related 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
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, ClinAssess GmbH
- Responsible party
- Principal investigator, PD Dr. med. Volker Heinemann, Ludwig-Maximilians - University of Munich
- Investigators
- Dominik Modest, PD Dr., Study chair, Ludwig-Maximilians - University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05217069
- Sponsor's protocol ID
- FIRE-6
- Status last verified
- Apr 2025
- First submitted
- 22 Jan 2019
- Last updated
- 16 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Avelumab Added to FOLFIRI Plus Cetuximab Followed by Avelumab Maintenance in Patients With Previously Untreated RAS Wild-type Colorectal Cancer. The Phase II FIRE-6 Study
- ClinicalTrials.gov ID
- NCT05217069
- Acronym / sponsor ID
- FIRE-6
- Conditions
- Treatment Related Cancer
- Keywords
- CRC, Avelumab, FIRE, RAS
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- Merck KGaA, Darmstadt, Germany, ClinAssess GmbH
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 18 Oct 2023 (actual)
- First posted
- 1 Feb 2022 (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.
Within the proposed single arm multicenter phase-II trial it is intended to investigate the feasi-bility of adding Avelumab to FOLFIRI plus Cetuximab after 4 cycles (2 months) of treatment with FOLFIRI plus Cetuximab. After 4 more cycles of FOLFIRI plus Cetuximab plus Avelumab the treatment will be de-escalated to Avelumab as a maintenance concept until progression of the disease according to RECIST 1.1 has occurred.
Detailed description
After 4-6 months of doublet chemotherapy a de-escalation to a less toxic regimen is needed for most of the patient with mCRC. The addition of Avelumab to a cytotoxic chemotherapy regimen with FOLFIRI plus cetuximab followed by Avelumab maintenance has not been in-vestigated so far. It is known that FOLFIRI plus cetuximab leads to necrosis and therefore tumor antigens that usually are not presented to the host immune system become recogniza-ble. This effect of a triggered immune system after induction treatment with chemotherapy is currently investigated in other trials. The ongoing IMPALA trial is testing the toll-like receptor (TLR)-9 agonist MGN1703 as maintenance treatment in patients that have responded to an induction doublet chemothera-py. This effect may be enhanced by the fact that Cetuximab in Combination with 5-FU and Irinotecan triggers immunogenic cell death.
The lately published data from the interim analysis of the PACIFIC trial using the anti-PD L1 antibody durvalumab after chemoradiation in stage II non-small cell lung cancer (NSCLC) proofed the concept of an anti-PD L1 antibody as a maintenance treatment after chemoradi-ation. Durvalumab prolonged PFS significantly (HR 0.52, p<0.001).
The study is not limited to MSI-h and should be able to demonstrate Avelumab efficacy in MSS tumors. The lately presented data on the use of atezolizumab plus cobimetinib (NCT01988896) in in heavily pretreated MSS mCRC patients showed a 12-month OS rate of 43% which was higher than the 24% seen for Regorafenib in the pivotal CORECT trial. Therefore it is worthwhile to test this concept in MSS mCRC.
Furthermore part of the cetuximab effect can be attributed to ADCC (antibody derived cellu-lar cyctotoxicity) with again leads to necrosis of tumor cells and the release of antigens. Both effects together may be able to present enough tumor-neo-antigens. To boost the effect, Avelumab is able to inhibit the PD-1 derived inhibition of cytolysis and other tumor cells within the body may be attacked by the immune system which leads to an anti-tumor effect repre-sented by a prolonged PFS and finally OS of the patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAS wild-type Avelumab | Other | Drug: 5-FU, Drug: Folinic Acid, Drug: Irinotecan, Drug: Cetuximab, Drug: AvelumabInduction therapy: FOLFIRI 5-FU: 400 mg/m2 (i.v. bolus) Folinic acid: 400mg/m2 Irinotecan: 180 mg/m2 5-FU: 2.400 mg/m2 (i.v. 46h) Cetuximab 400 mg/m2 i.v. 120min initial dose 250 mg/m2 i.v. 60min q 1w Maintenance therapy: Avelumab 10mg/kg IV (day 1 q2w) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Histologically confirmed, UICC stage IV adenocarcinoma of the colon or rectum with metastases (metastatic colorectal cancer), metastases primarily non-resectable or surgery refused by the patient
- RAS wild-type tumour status (KRAS and NRAS exon 2, 3, 4) (proven in the primary tumour or metastasis)
- Age ≥18
- ECOG performance status 0-1
- Patients suitable for chemotherapy administration
Key exclusion criteria (34 listed)
- Proof of a RAS mutation (KRAS or NRAS, exons 2, 3, 4 in the tumor (proven in the primary tumor or metastasis) or absence of testing for RAS mutation
- Primarily resectable metastases and the patient wishes for resection
- ≥ Grade II heart failure (NYHA classification)
- Myocardial infarction, balloon angioplasty (PTCA) with or without stenting, and cere-bral vascular accident/stroke within the past 12 months before start of study treat-ment, unstable angina pectoris, serious cardiac arrhythmia according to investigator's judgement requiring medication.
- Pre-existing pulmonary fibrosis or immune pneumonitis
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 |
|---|---|---|
| 5-FU400 mg/m2 (i.v. bolus) 2400 mg/m2 (i.v. 46h) | Drug | RAS wild-type Avelumab |
| Folinic Acid400mg/m2 | Drug | RAS wild-type Avelumab |
| Irinotecan180 mg/m2 | Drug | RAS wild-type Avelumab |
| Cetuximab400 mg/m2 i.v. 120min initial dose 250 mg/m2 i.v. 60min q 1w | Drug | RAS wild-type Avelumab |
| Avelumab10mg/kg IV (day 1 q2w) | Drug | RAS wild-type Avelumab |
Primary outcome
Progression free survival (PFS)
Time frame: up to 8 months
The primary clinical objective is to determine the efficacy of a standard 1st-line regimen (FOLFIRI plus cetuximab) in patients with RAS wild-type mCRC with Avelumab mainte-nance in terms of progression free survival rate after 8 months (according to RECIST 1.1).
3 secondary outcomes
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: up to 36 months
Efficacy of experimental Regimen according to response rate
Time frame: up to 36 months
Efficacy of experimental Regimen according to Overall survial
Time frame: up to 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 16 Apr 2025.
- Individual participant dataSharing planned: Undecided
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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.
Dominik Modest, PD Dr. study chair
Ludwig-Maximilians - University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing 5-FU, Folinic Acid and Irinotecan in people with Treatment Related Cancer, run by Ludwig-Maximilians - University of Munich at 1 site in Germany.
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 24 inclusion and 34 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 16 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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?
Progression free survival (PFS) (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Apr 2025.