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Cervical Cancer ≥ FIGO IIB and or Lymph Node MetastasesPhase 2CERAD-IMMUNENCT05504642

Chemo-radio-immunotherapy With Nivolumab and Ipilimumab Treatment in Locally Advanced Cervical Cancer Patients

A Phase 2 study testing Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab), Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab) and Maintenance Treatment (Nivolumab/Ipilimumab) in people with Cervical Cancer ≥ FIGO IIB and or Lymph Node Metastases, run by Universitätsklinikum Köln.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this study is to use Chemo-radio-immunotherapy and maintenance therapy with Nivolumab and Ipilimumab in order to achieve improved outcome in patients with locally advanced cervical cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab), Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab) and Maintenance Treatment (Nivolumab/Ipilimumab)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
1 Nov 2023to Jul 2026
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
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully-informed written consent.
  • Females ≥ 18 years of age
  • Histologically confirmed squamous cell, adeno- adenosquamous carcinoma of the cervix uteri. Surgical staging prior to treatement is optional.
  • FIGO stage ≥ IIB and/or histologically confirmed pelvic lymph node metastases.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1.
  • Adequate bone marrow, hepatic and renal function including the following:
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  • Haemoglobin ≥ 9.0 g/dL, absolute neutrophil count ≥ 1,500 /µL, platelets ≥100,000 /µL;
  • Total bilirubin ≤ 1.5 x upper normal limit; (except subjects with Gilbert Syndrome who can have total bilirubin < 3.0 mg/dL);
  • AST (SGOT), ALT (SGPT) ≤ 3 x upper normal limit;
  • International normalized ratio (INR) ≤ 1.25;
  • Creatinine ≤ 1.5 x upper normal limit OR measured or calculated creatinine clearance (according to Cockcroft-Gault) ≥40 mL/min for participant with creatinine levels >1.5 × institutional ULN (GFR can also be used in place of creatinine or CrCl)
  • Female patients with reproductive potential must have a negative urine or serum pregnancy test within 7 days prior to start of trial. Women must not be breastfeeding.
  • The patient is willing and able to comply with the protocol for the duration of the study, including hospital visits for treatment and scheduled follow-up visits and examinations.
  • WOCBP must agree to follow instructions for method(s) of contraception for the treatment time and 5 months after.

Who cannot join

  • Previous systemic therapy in the first-line setting.
  • Patients with neuroendocrine (small cell or large cell) tumors or mixed neuroendocrine histology.
  • Patients with histologically confirmed para-aortic lymph node metastases.
  • Prior organ allograft or allogeneic bone marrow transplantation.
  • Local therapies ongoing or completed <4 weeks prior to the baseline scan.
  • Thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism within the 6 months prior to the first dose of study drug with the exception of thrombosis of a segmental portal vein.
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  • Prior, systemic anti-cancer chemotherapy, radiotherapy administered <4 weeks prior to study entry, endocrine- or immunotherapy or use of other investigational agents.
  • Major surgery within 4 weeks of starting the study. Patients must have recovered from effects of major surgery.
  • Malignancies other than disease under study within 5 years prior to inclusion, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS rate >90%) treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated surgically with curative intent, ductal carcinoma in situ treated surgically with curative intent)
  • Any serious or uncontrolled medical disorder or active infection that, in the opinion of the investigator, may increase the risk associated with study participation, study drug administration, or would impair the ability of the subject to receive study drug.
  • Psychiatric disorders or altered mental status precluding understanding of the informed consent process and/or compliance with the study protocol.
  • Subjects with a history of or current CNS metastases. A scan to confirm the absence of brain metastases is not required. Patients with unknown CNS metastatic status and any clinical signs indicative of CNS metastases are eligible if CNS metastases are excluded using CT and/or MRI scans.
  • Pregnant or breast-feeding women.
  • Any positive test result for hepatitis B virus (e.g. surface antigen [HBV sAg, Australia antigen] positive) or hepatitis C virus (Hepatic C antibody [anti-HCV] positive, except if HCV-RNA negative.
  • Immunocompromised patients, e.g. patients with positive testing for HIV at screening visit or those under corticoid medication or immunosuppressive drugs (e.g. methotrexate).
  • Subjects with active, known, or suspected autoimmune disease. Subjects with Type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or skin disorders (such as vitiligo, psoriasis, or alopecia) not requiring systemic treatment are permitted to enroll. For any cases of uncertainty, it is recommended that the coordinating investigator be consulted prior to signing informed consent.
  • Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days prior to study drug administration. Inhaled or topical steroids, and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
  • Non-resolved (> Grade 1 (NCI CTCAE version 5) toxicities attributed to prior anti-cancer therapy other than hearing loss, alopecia and fatigue
  • > Grade 1 peripheral neuropathy according to CTCAE version 5.
  • History of allergy or hypersensitivity to study drugs or any constituent of the products
  • Patient is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.23.Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities § 40 Abs. 1 S. 3 Nr. 4 AMG.24.Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].

About this study

Official title: Nivolumab and Ipilimumab for Chemo-radio-immunotherapy Followed by Maintenance Therapy With Nivolumab and Ipilimumab for Primary Treatment in Locally Advanced Cervical Cancer Patients

The purpose of this study is to use Chemo-radio-immunotherapy and maintenance therapy with Nivolumab and Ipilimumab in order to achieve improved outcome in patients with locally advanced cervical cancer.

Read the detailed description

After being informed about the study and potential risks, all eligible patients giving written informed consent will undergo a Pre-Chemo-radio-immunotherapy Treatment with Nivolumab and Ipilimumab for 2 weeks. In the following week 1-7, concurrent Chemo-radio-Immunotherapy will consist of standard administration of concurrent Cisplatin mono during radiotherapy, with simultaneous application of Nivolumab and Ipilimumab according to trial protocol. This is followed by Maintenance Treatment for 6 months with Nivolumab and Ipilimumab according to trial protocol.

Being tested
Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab), Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab), Maintenance Treatment (Nivolumab/Ipilimumab)
Keywords
cervical cancer, lymph node metastases, FIGO IIB
Medical subject headings
Lymphatic Metastasis, Uterine Cervical Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab)Drug

    Two weeks before start of Chemo-radio-immunotherapy one administration of Nivolumab 3 mg/kg and Ipilimumab 1 mg/kg IV over 30 minutes, with a 30 minute break between Nivolumab and Ipilimumab.

  • Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab)Drug

    In week 1-7, standard administration of concurrent Cisplatin mono 40mg/m2 body surface area d1, 8, 15, 22, 29 (Monday of each treatment week) during radiotherapy. Simultaneous application of Nivolumab 3mg/kg week 1, 3, 5, 7 (on Thursday) and Ipilimumab 1mg/kg in week 5 (on Thursday).

  • Maintenance Treatment (Nivolumab/Ipilimumab)Procedure or surgery

    For six months after Chemo-radio-immunotherapy, Nivolumab 3mg/kg every two weeks x12 (week +2, +4, +6, +8, +10, +12, +14, +16, +18, +20, +22, +24 (twelve applications), each application over 30 minutes and Ipilimumab every six weeks x4 (week +6,+12, +18, +24).

Study groups in NCT05504642
Study groupRoleWhat they receive
Study medicationExperimentalAll eligible patients will receive study medication: * Pre-Chemo-radio-immunotherapy Treatment for two weeks before start of Chemo-radio-immunotherapy * Concurrent Chemo-radio-immunotherapy (week 1-7) * Maintenance Treatment (six months) after Chemo-radio-immunotherapy
Receives: Drug: Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab); Drug: Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab); Procedure: Maintenance Treatment (Nivolumab/Ipilimumab)

What is being measured

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

  1. Progression free survival (PFS)

    Tumor response assessed by MRI Pelvic according to resist

    Measured: From Baseline to 2 years

  2. The adverse events according to NCI-CTCAE v5.0

    Safety and tolerability (according to NCI-CTCAE v5.0)

    Measured: From the time of signed informed consent until 100 days after the last study drug administration

Timeline

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

  1. First posted17 Aug 2022
  2. Study start1 Nov 2023 (estimated)
  3. Primary completionJun 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Why it stopped: Study stopped before submission for funding reasons

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Open-label, single-arm, monocenter phase II trial
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05504642
Sponsor's protocol ID
Uni-Koeln-4513
Acronym
CERAD-IMMUNE
Status last verified
Apr 2023
First submitted
1 Mar 2022
Last updated
18 Apr 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pre-Chemo-radio-immunotherapy Treatment (Nivolumab/Ipilimumab), Concurrent Chemo-radio-immunotherapy (Nivolumab/Ipilimumab) and Maintenance Treatment (Nivolumab/Ipilimumab) in people with Cervical Cancer ≥ FIGO IIB and or Lymph Node Metastases, run by Universitätsklinikum Köln.

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 14 inclusion and 22 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: withdrawn, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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: From Baseline to 2 years). The study lists 2 primary outcomes in all. 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 NCT05504642.

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 18 Apr 2023.

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