TSR-042 as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation (ATOMICC)

June 15, 2026 updated by: Grupo Español de Investigación en Cáncer de Ovario

A Randomized, Open Label, Phase II Trial of Anti-PD1, TSR-042, as Maintenance Therapy for Patients With High-risk Locally Advanced Cervical Cancer After Chemo-radiation

Patients with locally advanced cervical cancer (LACC) despite definitive chemo-radiotherapy, has a poor progression-free survival (PFS) and overall survival (OS). The hypothesis is that the use of TSR-042, checkpoint inhibitor, as consolidation therapy following concurrent chemo-radiation would increase PFS in these patients. The incorporation of immunotherapy after chemo-radiation is one the best scenarios for this approach, since takes advantages of "the ideal microenvironment" created after radiation. In a similar rationale, the phase 3 study that compared the anti-programmed death ligand 1 antibody durvalumab as consolidation therapy with placebo in patients with stage III NSCLC who did not have disease progression after two or more cycles of platinum-based chemoradiotherapy, showed that progression-free survival was significantly longer with durvalumab than with placebo in all sub-groups regardless of response obtained to chemotherapy, namely patients with stable disease (SD) gained the same benefit that patients with partial response (PR). Due to the aforementioned biology of cervical cancer, the proven activity of anti programmed cell death protein 1 (Anti-PD1) agents in metastatic and/or recurrent cervical cancer and the poor PFS and OS in patients with LACC despite definitive chemo-radiotherapy, we consider to analyze the Anti-PD1 agent, TSR-042 as maintenance therapy after concurrent chemo-radiation (CCRT)

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
134

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Spain
      • Barcelona, Spain
        • Hospital Clinic
      • Barcelona, Spain, 08035
        • H Vall d'Hebron
      • Córdoba, Spain, 14004
        • H Reina Sofía Cordoba
      • Hospitalet Del Llobregat, Spain
        • ICO Hospitalet
      • Madrid, Spain
        • Hospital Ramon y Cajal
      • Madrid, Spain
        • Hospital Clinico San Carlos
      • Madrid, Spain
        • Clinica Universitaria de Navarra
      • Murcia, Spain
        • Hospital Universitario Morales Meseguer
      • Murcia, Spain
        • Hospital Clinico Universitario Virgen Arrixaca
      • Málaga, Spain
        • Hospital Virgen de la Victoria
      • Palma de Mallorca, Spain
        • Hospital Son Llatzer
      • Palma de Mallorca, Spain
        • Hospital Son Espases
      • Sabadell, Spain, 08208
        • H. Parc Tauli
      • Santander, Spain
        • Hospital Marqués de Valdecilla
      • Terrassa, Spain
        • Hospital de Terrassa
    • Alicante
      • Elche, Alicante, Spain
        • Hospital General Universitario de Elche
    • Gipuzkoa
      • Donostia / San Sebastian, Gipuzkoa, Spain, 20014
        • Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea
    • Girona
      • Girona, Girona, Spain, 17007
        • ICO Girona
    • Madrid
      • Madrid, Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Madrid, Spain
        • Hospital Universitario 12 de Octubre
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Hospital Alvaro Cunqueiro
    • Sevilla
      • Seville, Sevilla, Spain
        • Hospital Universitario Virgen del Rocío
    • Valencia
      • Valencia, Valencia, Spain, 46010
        • Hospital Clínico Universitario de Valencia
      • Valencia, Valencia, Spain, 46026
        • Hospital La Fe
      • Valencia, Valencia, Spain, 46009
        • Instituto Valenciano de Oncología
  • Turkey (Türkiye)
    • Anadolu Bölgesi
      • Ankara, Anadolu Bölgesi, Turkey (Türkiye), 06200
        • Ankara Oncology Training and Research Hospital
      • Ankara, Anadolu Bölgesi, Turkey (Türkiye), 06800
        • Ankara City Hospital
      • Ankara, Anadolu Bölgesi, Turkey (Türkiye), 06800
        • Hacettepe University
    • Sarıyer
      • Istanbul, Sarıyer, Turkey (Türkiye), 34457
        • Acibadem Maslak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Signed informed consent before any study-specific procedure
  2. Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  3. Participant must be a female ≥ 18 years of age
  4. Life expectancy ≥3 months
  5. Participant must have biopsy-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
  6. Patients must have archival tumor tissue available that is formalin-fixed and paraffin embedded.

  7. At diagnosis:

    • Federation of Gynecologists and Obstetricians (FIGO) stages IB2, IIA2, IIB with pelvic lymph node involvement: Biopsy-proven pelvic node involvement, 2 or more positive nodes by magnetic resonance imaging (MRI) or computed tomography (CT) (≥1.5 cm shortest dimension), 2 or more positive nodes by Positron Emission Tomography (PET) (with standardized uptake values (SUV) ≥2.5)
    • FIGO stages IIIA, IIIB, IVA
    • Any FIGO stage with para-aortic lymph node involvement: Biopsy-proven para-aortic node involvement, 1 or more positive nodes by MRI or CT (≥1.5 cm shortest dimension), 1 or more positive pelvic nodes by PET (with SUV ≥ 2.5)
  8. Subjects must have received combination chemotherapy and radiotherapy (CCRT) with curative intent. Patients must have received at least 4 doses of weekly cisplatin.
  9. Patients must have completed definitive treatment, namely chemo-radiation, up to 12 weeks prior to sign the Informed Consent form.
  10. Toxicities resulting from chemo-radiation must resolve to ≤ Grade 1 prior to randomization.

  11. Participant must have adequate organ function, defined as follows:

    • Absolute neutrophil count ≥ 1,500/µL
    • Platelets ≥ 100,000/µL
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine ≤ 1.5× upper limit of normal (ULN) or calculated creatinine clearance ≥ 50 mL/min using Cockcroft-Gault equation for patients with creatinine levels > 1.5× institutional ULN
    • Total bilirubin ≤ 1.5× ULN OR direct bilirubin ≤ 1× ULN
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5× ULN unless liver metastases are present, in which case they must be ≤ 5× ULN
    • International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
  12. Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  13. Negative Test Results for Hepatitis
  14. Female participant has a negative serum pregnancy test within 72 hours prior to taking study treatment if of childbearing potential and agrees to abstain from activities that could result in pregnancy from screening through 150 days after the last dose of study treatment, or is of nonchildbearing potential.
  15. Participant must agree to not breastfeed during the study or for 150 days after the last dose of study treatment.
  16. Male partners must agree to use an adequate method of contraception starting with the first dose of study treatment through 150 days after the last dose of study treatment.
  17. Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent

Exclusion Criteria:

  1. Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers.
  2. FIGO Stage IVB (cancer has spread distantly).
  3. Subjects who have undergone a previous hysterectomy defined as removal of the entire uterus or will have a hysterectomy as part of their initial cervical cancer therapy.
  4. Has not achieved at least a partial response by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 after completion of CCRT administered with curative intent.
  5. Patients previously treated with chemotherapy except when used concurrently with radiation therapy. Patients who have received either concurrent paclitaxel with radiation therapy or carboplatin/paclitaxel as adjuvant therapy are ineligible for the study.
  6. Prior treatment with any anti-vascular endothelial growth factor (anti-VEGF) drug, including bevacizumab, CD137 agonists or immune checkpoint blockade therapies, anti-PD1, or anti-PDL1 therapeutic antibodies or anti-CTLA 4.
  7. Patients with a concomitant malignancy other than non-melanoma skin cancer.
  8. History of autoimmune disease
  9. History of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  10. History of interstitial lung disease.
  11. Active tuberculosis.
  12. Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1.
  13. Administration of a live, attenuated vaccine within 14 days before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study Influenza vaccination should be given during influenza season only. Patients must not receive live, attenuated influenza vaccine (e.g., FluMist®) within 4 weeks prior to Cycle 1, Day 1 or at any time during the study.
  14. Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1.
  15. Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1.
  16. Women that are breastfeeding or pregnant.
  17. Demonstration of any other disease, neurological or metabolic dysfunction, found upon physical examination or laboratory tests involving a reasonable suspicion of the existence of a disease or condition that contraindicates the use of an experimental drug, or that involves an increased risk to the patient of treatment-related complications.
  18. No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment
  19. Participant must not be simultaneously enrolled in any interventional clinical trial
  20. Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  21. Participant must not have received investigational therapy ≤ 4 weeks, or within a time interval less than at least 5 half-lives of the investigational agent, whichever is shorter, prior initiating protocol therapy.
  22. Participant has had radiation therapy encompassing >20% of the bone marrow within 2 weeks; or any radiation therapy within 1 week prior to Day 1 of protocol therapy.
  23. Participant must not have a known hypersensitivity to TSR-042 components or excipients.
  24. Participant must not have a serious, uncontrolled medical disorder or nonmalignant systemic disease. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, chronic obstructive pulmonary disease, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent
  25. Participant must not have known, symptomatic brain or leptomeningeal metastases
  26. Patient experienced ≥ Grade 3 immune-related adverse events (AE) with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
  27. Participant has a known history of human immunodeficiency virus (type 1 or 2 antibodies).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: No further treatment
Other: No Further Treatment
No further treatment
Experimental: TSR-042
TSR-042 treatment administered using a 30 -minute IV infusion (with a -5 minute and +15 minute window permitted).
Drug: TSR-042
Fixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: 30 months
Time from the date of randomization to the date of first documentation of disease progression or death due to any cause, whichever occurs first based on investigator assessment using the Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v 1.1)
30 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Frequency and severity of adverse events (AEs)
Time Frame: 30 months
Incidence, nature and severity of adverse events (AEs) assessed by CTCAE version 4.03
30 months
Overall survival (OS)
Time Frame: 30 months
Time from the date of randomization to the date of death due to any cause
30 months
Patient reported outcomes (PROs) of health-related quality of life (HRQOL)
Time Frame: 30 months
Mean changes from baseline score assessed by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)
30 months
Patient reported outcomes (PROs) of health-related quality of life (HRQOL)
Time Frame: 30 months
Mean changes from baseline score assessed by EQ -5D-5L.
30 months
Patient reported outcomes (PROs) of fatigue
Time Frame: 30 months
Mean changes from baseline score assessed by the PROMIS-Cancer-Fatigue Short Form 4a.
30 months
Patient reported outcomes (PROs) of pain
Time Frame: 30 months
Mean changes from baseline score assessed by a single item of the Brief Pain Inventory (BPI).
30 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Grupo Español de Investigación en Cáncer de Ovario

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Apices Soluciones S.L.
GSK/TESARO

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ana Oaknin, PhD, Hospital Vall d'hebrón

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 28, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GEICO 78-C (ATOMICC)
  • 2018-002155-15 (EudraCT Number)
  • 2023-510268-11-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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