Cervix CancerCOLIBRINCT04256213
COL Immunotherapy Before Radiochimio + Ipilimumab
A study testing Nivolumab and Ipilimumab in people with Cervix Cancer, run by ARCAGY/ GINECO GROUP at 8 sites in France.
Trial summary
This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cervix Cancer
- What is being tested?
- Nivolumab and Ipilimumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 8 sitesFrance
- Study dates
- 2 Jul 2020to 4 Aug 2024
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed diagnosis of cervical squamous cell carcinoma stage IB3 to IVA, (FIGO 2018)
- Patients requiring RT-CT therapy as standard of care
- Age ≥18
- Patient accepting to undergo a new cervix biopsy
- Adequate marrow function:
- White blood cell (WBC) >2000/mm3 (stable off any growth factor within 4 weeks of first study drug administration)
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- Neutrophils >1500/ mm3 (stable off any growth factor within 4 weeks of first study drug administration)
- Platelets > 100× 103/mm3 (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
- Hemoglobin > 8 g/dL (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
- Adequate other organ functions:
- ALT and AST < 3× institutional ULN
- Total bilirubin < 1.5× institutional ULN (except subjects with Gilbert's Syndrome who must have normal direct bilirubin)
- Normal thyroid function, subclinical hypothyroidism (thyroid-stimulating hormone [TSH] < 10 mIU/mL) or have controlled hypothyroidism on appropriate thyroid supplementation
- Serum creatinine < 2× ULN or creatinine clearance (CrCl) > 40 mL/min (measured using the Cockcroft-Gault formula or the MDRD formula for patients older than 65 years-old
- General Health as evidenced by PS ≤2
- Covered by a medical insurance
- Signed and dated informed consent form prior to any study-specific procedure.
- Stated willingness to comply with all study procedures and availability for the duration of the study
- Women of childbearing potential must have a negative serum or urine pregnancy test For females of reproductive potential: use of highly effective contraception and for at least 5 months after administration of the last dose of nivolumab. A woman is considered to be of childbearing potential if she is postmenarcheal, has not reached a postmeno-pausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries, fallopian tubes, and/or uterus).
- All subjects must consent to allow the acquisition of blood samples, FFPE tumor tissue, either a block or 15 to 20 unstained slides, and fresh tumor for performance of correlative studies.
Who cannot join
- Pregnant or breastfeeding women.
- Patient concurrently using other approved or investigational antineoplastic agents.
- Patient candidate for neo adjuvant CT before RT-CT
- Any contraindication to nivolumab or ipilimumab treatments as per Nivolumab and Ipilimumab Investigator's Brochure
- Prior therapy with an immune checkpoint inhibitor
- Prior history of other malignancies other than study disease (except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix) unless the patient has been free of the disease for at least 3 years.
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- Immune-deficient status (patients with HIV, immunosuppressive treatment, haematological malignancies, and previous organ transplantation)
- History of any chronic hepatitis as evidenced by:
- Positive test for hepatitis B surface antigen
- Positive test for qualitative hepatitis C viral load (by polymerase chain reaction [PCR])
- Note: Subjects with positive hepatitis C antibody and negative quantitative hepatitis C by PCR are eligible. History of resolved hepatitis A virus infection is not an exclusion criterion
- Uncontrolled or significant cardiovascular disease including, but not limited to, any of the following:
- Myocardial infarction or stroke/transient ischemic attack within the past 6 months
- Uncontrolled angina within the past 3 months
- History of other clinically significant heart disease (eg, cardiomyopathy, congestive heart failure with New York Heart Association functional classification III-IV, pericarditis, significant pericardial effusion, or myocarditis)
- Any history of clinically significant arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or torsades de pointes)
- QT interval corrected for heart rate using Fridericia's formula (QTcF) prolongation > 480 msec
- Cardiovascular disease-related requirement for daily supplemental oxygen therapy
- Subjects with known or suspected CNS metastases, untreated CNS metastases, are excluded.
- Note: However, subjects with controlled brain metastases will be allowed to enroll. Controlled brain metastases are defined as no radiographic progression for at least 4 weeks following radiation and/or surgical treatment (or 4 weeks of observation if no intervention is clinically indicated), and off of steroids for at least 2 weeks, and no new or progressive neurological signs and symptoms.
- Patients requiring concomitant treatment with therapeutic doses of anticoagulants will not be eligible for this clinical trial.
- Note: Patients treated with low dose of anticoagulants for thrombo-embolic events prophylaxis are allowed.
- Any major surgery within 4 weeks of study drug administration. Subjects must have recovered from the effects of major surgery or significant traumatic injury at least 14 days before the first dose of study drug.
- Note: Pelvic and aortic dissection is not considered as traumatic surgery, and therefore can be performed if clinically indicated.
- Subjects with active, known or suspected autoimmune disease. Note: Subjects with skin disorders (such as vitiligo, psoriasis or alopecia), type I diabetes mellitus, hypothyroidism only requiring hormone replacement or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- Note: Inhaled or topical steroids, and adrenal replacement doses are permitted in the absence of active autoimmune disease.)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
France8 sites
Centre François Baclesse
Caen, 14000
Centre Léon Bérard
Lyon, 69008
Groupe Hospitalier Diaconesses - Croix Saint-Simon
Paris, 75020
Institut Curie
Paris, 75278
Centre Armoricain de Radiothérapie, Imagerie médicale et Oncologie, CARIO-HPCA
Plérin, 22190
Institut Jean Godinot
Reims, 51726
Institut Claudius Regaud IUCT-O
Toulouse, 31059
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54519
About this study
Official title: A Multicenter, Pilot Study Evaluating Immune Impact and Safety of Nivolumab in Combination with Ipilimumab (immune Combination) Before Initial RT-CT Treatment for Cervix Cancer.: the French GINECO - COLIBRI Study
This is a multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy
Read the detailed description
The aim of COLIBRI is to evaluate the evolution of the CD8+/FOXP3+ ratio of lymphocytes in pre- versus post-treatment biopsies in patients treated with a combination of Nivolumab and Ipilimumab in a pilot study, just before starting standard RT-CT.
The study will also assess tolerability, Objective Response Rate, clinical activity and biological (dynamic) changes of the immune micro environment
- Conditions
- Cervix Cancer
- Being tested
- Nivolumab and Ipilimumab
- Keywords
- Cervix cancer, Immune combination
- Medical subject headings
- Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nivolumab and IpilimumabDrug
Nivolumab, IV D1C1 and D15C1 (before RT-CT) at 3 mg/kg Every 28 days at 480 mg during 6 months after RT-CT
Ipilimumab, 1 mg/kg, IV D1C1 (before RT-CT)
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab + Ipilimumab | Experimental | Not described Receives: Drug: Nivolumab and Ipilimumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CD8+/FOXP3+ relative change of lymphocytes from pre to post treatment biopsies
Measured: Baseline, before RT-CT
Secondary outcomes (4)
Adverse events
Assessed by CTCAE 4.03
Measured: Up to 100-days after end of treatment or until initiation of alternative cancer therapy
Objective Response Rate
Measured: 1week before RT-CT, 4 weeks after RT-CT
Progression Free Survival
Measured: 1 year
Overall Survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start2 Jul 2020
- Primary completion30 Aug 2021
- Study completion4 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervix 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 N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- ARCAGY/ GINECO GROUP
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Responsible party
- Sponsor
- Investigators
- Isabelle RAY-COQUARD, MD, PhD, Principal investigator, Centre Leon Berard
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04256213
- Sponsor's protocol ID
- GINECO-CE108b
- Other IDs
- 2019-002271-34, 2019
- Acronym
- COLIBRI
- Status last verified
- Dec 2024
- First submitted
- 27 Jan 2020
- Last updated
- 12 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Pilot Study Evaluating Immune Impact and Safety of Nivolumab in Combination with Ipilimumab (immune Combination) Before Initial RT-CT Treatment for Cervix Cancer.: the French GINECO - COLIBRI Study
- ClinicalTrials.gov ID
- NCT04256213
- Acronym / sponsor ID
- COLIBRI / GINECO-CE108b
- Conditions
- Cervix Cancer
- Keywords
- Cervix cancer, Immune combination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- ARCAGY/ GINECO GROUPUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb
- Study start
- 2 Jul 2020 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 4 Aug 2024 (actual)
- First posted
- 5 Feb 2020 (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 multicenter, single arm pilot study evaluating the biological impact of "Nivolumab + Ipilimumab" in patients with cervical squamous cell carcinoma requiring RT-CT as initial therapy
Detailed description
The aim of COLIBRI is to evaluate the evolution of the CD8+/FOXP3+ ratio of lymphocytes in pre- versus post-treatment biopsies in patients treated with a combination of Nivolumab and Ipilimumab in a pilot study, just before starting standard RT-CT.
The study will also assess tolerability, Objective Response Rate, clinical activity and biological (dynamic) changes of the immune micro environment
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nivolumab + Ipilimumab | Experimental | Drug: Nivolumab and Ipilimumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Histologically confirmed diagnosis of cervical squamous cell carcinoma stage IB3 to IVA, (FIGO 2018)
- Patients requiring RT-CT therapy as standard of care
- Age ≥18
- Patient accepting to undergo a new cervix biopsy
- Adequate marrow function:
Key exclusion criteria (27 listed)
- Pregnant or breastfeeding women.
- Patient concurrently using other approved or investigational antineoplastic agents.
- Patient candidate for neo adjuvant CT before RT-CT
- Any contraindication to nivolumab or ipilimumab treatments as per Nivolumab and Ipilimumab Investigator's Brochure
- Prior therapy with an immune checkpoint inhibitor
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 |
|---|---|---|
| Nivolumab and IpilimumabNivolumab, IV D1C1 and D15C1 (before RT-CT) at 3 mg/kg Every 28 days at 480 mg during 6 months after RT-CT Ipilimumab, 1 mg/kg, IV D1C1 (before RT-CT) | Drug | Nivolumab + Ipilimumab |
Primary outcome
CD8+/FOXP3+ relative change of lymphocytes from pre to post treatment biopsies
Time frame: Baseline, before RT-CT
4 secondary outcomes
Adverse events
Time frame: Up to 100-days after end of treatment or until initiation of alternative cancer therapy
Objective Response Rate
Time frame: 1week before RT-CT, 4 weeks after RT-CT
Progression Free Survival
Time frame: 1 year
Overall Survival
Time frame: 3 years
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 12 Dec 2024.
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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.
Isabelle RAY-COQUARD, MD, PhD principal investigator
Centre Leon Berard
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nivolumab and Ipilimumab in people with Cervix Cancer, run by ARCAGY/ GINECO GROUP at 8 sites in France.
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 20 inclusion and 27 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 12 Dec 2024. 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 France. 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.
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?
CD8+/FOXP3+ relative change of lymphocytes from pre to post treatment biopsies (time frame: Baseline, before RT-CT). 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 12 Dec 2024.