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Cervical CancerPhase 1/2NiCOLNCT03298893

Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months (NiCOL)

A Phase 1/2 study testing Nivolumab Injection, Cisplatin and radiotherapy in people with Cervical Cancer and Locally Advanced Cervical Cancer, run by Institut Curie at 3 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as monotherapy, and the next logical step is to evaluate rational therapeutic associations. Read more about this study

Who is it for?
Ages 18 to 99 years, women only
What is being tested?
Nivolumab Injection, Cisplatin and radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
3 sitesFrance
Study dates
27 Nov 2017to 7 Mar 2022
Phase
Phase 1/2
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 99 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult patients at least 18 years of age;
  • Ability to understand and the willingness to sign a written informed consent document.;
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1;
  • Histologically confirmed locally advanced cervical cancer, i.e. FIGO stages IB2 to IVA, squamous-cell carcinoma or adenocarcinoma, with indication for radiotherapy and cisplatin-based chemotherapy with a curative intent as confirmed by a multidisciplinary board including a radiation oncologist. PD-L1 expression on tumor will not be required for inclusion; (staging may include [18F]-fluorodeoxyglucose (FDG) PET-CT and/or para-aortic dissection in accordance with usual practice in each investigational center and at the Investigator's discretion);
  • Disease amenable to biopsy since three tumor samples are mandatory prior to treatment;
  • Laboratory values at Screening must meet the following criteria :
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  • neutrophils ≥ 1.0 x 109/L, lymphocytes ≥ 0.5 x 109/L, platelets ≥ 100 x 109/L, hemoglobin ≥ 8.0 g/dL, creatinine ≤ 2 times the upper limit of normal (ULN), aspartate aminotransferase (AST) ≤ 3 ULN, alanine aminotransferase (ALT) ≤ 3 x ULN, total bilirubin ≤ 1.5 x ULN (≤ 3 x ULN if genetically documented Gilbert's syndrome).
  • For women with child-bearing potential, negative blood or urinary pregnancy test within 24 hours of initiation of nivolumab, as well as appropriate method of contraception throughout the study ;
  • Affiliated to the French Social Security System.

Who cannot join

  • Metastases (except pelvic and/or para-aortic nodal metastases) ;
  • Peritoneal carcinosis;
  • Sensory or motor neuropathy ≥ grade 2;
  • Active or recent history of known autoimmune disease or recent history of a syndrome that required systemic corticosteroids or immunosuppressive drugs, except for :
  • hydrocortisone, which is permitted at physiological doses;
  • syndromes that would not be expected to recur in the absence of an external trigger, e.g. glomerulonephritis;
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  • vitiligo or autoimmune thyroiditis;
  • Type-1 or type-2 diabetes;
  • History of or current immunodeficiency disease, including known history of infection with human immunodeficiency virus;
  • Prior systemic treatment or radiotherapy for cervical cancer;
  • Prior allogeneic stem cell transplantation;
  • Prior immunotherapy, including tumor vaccine, cytokine, anti-CTLA4, anti-PD-1, anti-PD-L1 or similar agents;
  • Any non-oncologic vaccine for prevention of infectious disease within 28 days prior to inclusion, including but not limited to measles, mumps, rubella, chicken pox, yellow fever, seasonal influenza, H1N1, rabies, BCG, and typhoid vaccine;
  • Positive serology for hepatitis B surface antigen;
  • Positive for hepatitis-C ribonucleic acid on polymerase chain reaction;
  • Active infection requiring therapy;
  • History of idiopathic pulmonary fibrosis (including pneumonitis), drug-induced pneumonitis, organizing pneumonia or evidence of active pneumonitis on chest CT-scan at Screening;
  • History of malignancy (excepting non-melanoma skin cancer) unless complete remission was achieved at least 3 years prior to inclusion and no additional therapy is required or planned during the study;
  • Underlying medical condition that, in the Investigator's opinion, could render the administration of the study treatment hazardous; additional severe and/or uncontrolled concurrent disease;
  • Concomitant use of other investigational drugs;
  • Pregnancy or breastfeeding.

Trial locations and contacts

3 sites in 1 country.

France3 sites

  • Institut Curie

    Paris, 75005

  • Hopital Européen Georges Pompidou

    Paris, 75015

  • Institut Curie Hopital René Huguenin

    Saint-Cloud, 9220

Other trials in France

About this study

Official title: A Phase-I Study of Nivolumab in Association With Radiotherapy and Cisplatin in Locally Advanced Cervical Cancers Followed by Adjuvant Nivolumab for up to 6 Months. NiCOL

To date, the majority of clinical trials on checkpoint inhibitors have tested these agents as monotherapy, and the next logical step is to evaluate rational therapeutic associations. The aim of the NiCOL study is to assess the safety of nivolumab in association with chemoradiation therapy and to gain initial insight into its efficacy in association with the current standard of care, including chemoradiation.

Being tested
Nivolumab Injection, Cisplatin, radiotherapy
Keywords
cervical cancer, nivolumab, cisplatin, radiotherapy
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 InjectionDrug

    2 possible doses : flat dose 240 mg q2 weeks or 1mg/kg q2 weeks

  • CisplatinDrug

    40 mg/m2, once a week during radiotherapy

  • radiotherapyRadiation

    Intensity-modulated radiation therapy (including volumetric-modulated arc therapy and tomography) will be used. A dose of 45 Gy will be delivered to the pelvis in 25 fractions of 1.8 Gy using a 6-MV photon energy.

    An additional dose of 54 Gy in 25 fractions of 2.16 Gy may be delivered to invaded lymph nodes using SIB-IMRT.

    An additional lateral pelvic dose may be delivered if coverage of the target volumes is judged insufficient. The volumes, doses and techniques will be those usually used in each center.

Study groups in NCT03298893
Study groupRoleWhat they receive
Nivolumab + radiochemotherapyExperimental5 weeks of radiochemotherapy + nivolumab followed by 5 months of nivolumab alone
Receives: Drug: Nivolumab Injection; Drug: Cisplatin; Radiation: radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. rate of occurrence of dose-limiting toxicity (DLT)

    DLT is defined as any of the following treatment-related adverse events or laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.0:

    • non-hematological toxicity ≥ grade 3;
    • immune-related adverse event ≥ grade 3;
    • symptomatic immune-related adverse event ≥ grade 2 resistant to optimal supportive care for > 7 days;
    • dosing delay in RT ≥ 1 week due to toxicity related to nivolumab, chemotherapy or RT;
    • colitis or diarrhea ≥ grade 3.

    Measured: within 11 weeks after the initiation of treatment.

Secondary outcomes (9)

  1. Objective Response Rate (ORR)

    ORR is defined as the proportion of all subjects whose best response is either a complete response or a partial response.

    Measured: after the end of RT and before brachytherapy and again up to 2 months after brachytherapy

  2. Progression Free Survival (PFS)

    PFS is defined as the length of time from the start of treatment to disease progression or death, regardless of the cause of death

    Measured: 2 years

  3. Disease Free Survival (DFS)

    DFS is defined as the length of time from the start of complete response to the time of relapse from complete response. DFS applies only to patients in complete response.

    Measured: 2 years

  4. Incidence of Serious Adverse Events (SAEs) to assess the overall safety profile of the association of nivolumab and pelvic radio-chemotherapy

    Measured: from the first intake of the IMP until 100 days after the last intake of the IMP

  5. Incidence of Adverse Events (AEs) to assess the overall safety profile of the association of nivolumab and pelvic radio-chemotherapy

    Measured: from the first intake of the IMP until 100 days after the last intake of the IMP

  6. validation of molecular alterations detected by molecular analyses

    Retrospective exome, RNA and targeted sequencing analyses will be performed on all patients treated and for whom tumor samples are available.

    Measured: 2 years

  7. ctDNA heterogeneity

    Retrospective exome and targeted sequencing analyses will be performed on all patients treated and for whom tissue samples are available at the different timepoints

    Measured: baseline, at Weeks 3, 6 and 12 and every 12 weeks up to Week 104

  8. tumor microenvironment description

    phenotypic analysis of the different components of the tumor microenvironment using various technologies

    Measured: 2 years

  9. tumor PD-L1 immunohistochemistry

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2017
  2. Study start27 Nov 2017
  3. Primary completion30 Oct 2020
  4. Study completion7 Mar 2022

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03298893
Sponsor's protocol ID
IC 2016-08
Acronym
NiCOL
Status last verified
Sep 2025
First submitted
27 Sep 2017
Last updated
19 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Sponsor will share de-identified data sets. Documents generated under the project will be disseminated in accordance with Institut Curie policies.

Publications

  • Rodrigues M, Vanoni G, Loap P, Dubot C, Timperi E, Minsat M, Bazire L, Durdux C, Fourchotte V, Laas E, Pouget N, Castel-Ajgal Z, Marret G, Lesage L, Meseure D, Vincent-Salomon A, Lecompte L, Servant N, Vacher S, Bieche I, Malhaire C, Huchet V, Champion L, Kamal M, Amigorena S, Lantz O, Chevrier M, Romano E. Nivolumab plus chemoradiotherapy in locally-advanced cervical cancer: the NICOL phase 1 trial. Nat Commun. 2023 Jun 22;14(1):3698. doi: 10.1038/s41467-023-39383-8.

    PubMed 37349318

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Nivolumab Injection, Cisplatin and radiotherapy in people with Cervical Cancer and Locally Advanced Cervical Cancer, run by Institut Curie at 3 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 9 inclusion and 21 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 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

rate of occurrence of dose-limiting toxicity (DLT) (time frame: within 11 weeks after the initiation of treatment.). 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 NCT03298893, 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 19 Sep 2025.

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