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Cervical CancerPhase 2ATOMICCNCT03833479

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

A Phase 2 study testing No Further Treatment and TSR-042 in people with Cervical Cancer and Advanced Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 29 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Cervical Cancer, Advanced Cancer
What is being tested?
No Further Treatment and TSR-042
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
134 participants
Where
29 sitesin 2 countries
Study dates
28 Jun 2019to 31 Jul 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

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

  • Signed informed consent before any study-specific procedure
  • Participant must have an Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 1
  • Participant must be a female ≥ 18 years of age
  • Life expectancy ≥3 months
  • Participant must have biopsy-confirmed squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma of the cervix.
  • Patients must have archival tumor tissue available that is formalin-fixed and paraffin embedded.
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  • 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)
  • Subjects must have received combination chemotherapy and radiotherapy (CCRT) with curative intent. Patients must have received at least 4 doses of weekly cisplatin.
  • Patients must have completed definitive treatment, namely chemo-radiation, up to 12 weeks prior to sign the Informed Consent form.
  • Toxicities resulting from chemo-radiation must resolve to ≤ Grade 1 prior to randomization.
  • 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
  • Participant must agree to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Negative Test Results for Hepatitis
  • 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.
  • Participant must agree to not breastfeed during the study or for 150 days after the last dose of study treatment.
  • 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.
  • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent

Who cannot join

  • Histological types other than in inclusion criteria, like sarcomas, small cell carcinoma with neuroendocrine differentiation, non-epithelial cancers.
  • FIGO Stage IVB (cancer has spread distantly).
  • 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.
  • 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.
  • 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.
  • 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.
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  • Patients with a concomitant malignancy other than non-melanoma skin cancer.
  • History of autoimmune disease
  • History of idiopathic pulmonary fibrosis, organizing pneumonia , drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan.
  • History of interstitial lung disease.
  • Active tuberculosis.
  • Signs or symptoms of infection within 2 weeks prior to Cycle 1, Day 1.
  • 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.
  • Treatment with systemic immunostimulatory agents within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to Cycle 1, Day 1.
  • Treatment with systemic immunosuppressive medications within 2 weeks prior to Cycle 1, Day 1.
  • Women that are breastfeeding or pregnant.
  • 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.
  • No medical or psychiatric illness that may impede the performance of a systemic or surgical treatment
  • Participant must not be simultaneously enrolled in any interventional clinical trial
  • Participant must not have had major surgery ≤ 3 weeks prior to initiating protocol therapy and participant must have recovered from any surgical effects.
  • 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.
  • 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.
  • Participant must not have a known hypersensitivity to TSR-042 components or excipients.
  • 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
  • Participant must not have known, symptomatic brain or leptomeningeal metastases
  • Patient experienced ≥ Grade 3 immune-related adverse events (AE) with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
  • Participant has a known history of human immunodeficiency virus (type 1 or 2 antibodies).

Trial locations and contacts

29 sites in 2 countries.

29 sites in 2 countries

Spain25 sites

  • H Vall d'Hebron

    Barcelona, 08035

  • Hospital Clínic

    Barcelona

  • H Reina Sofía Cordoba

    Córdoba, 14004

  • Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante

  • ICO Girona

    Girona, Girona, 17007

  • ICO Hospitalet

    Hospitalet Del Llobregat

  • Hospital Universitario La Paz

    Madrid, Madrid, 28046

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid

  • Clinica Universitaria de Navarra

    Madrid

  • Hospital Clínico San Carlos

    Madrid

  • Hospital Ramon y Cajal

    Madrid

  • Hospital Virgen de la Victoria

    Málaga

  • Hospital Clinico Universitario Virgen Arrixaca

    Murcia

  • Hospital Universitario Morales Meseguer

    Murcia

  • Hospital Son Espases

    Palma de Mallorca

  • Hospital Son Llatzer

    Palma de Mallorca

  • H. Parc Taulí

    Sabadell, 08208

  • Hospital Marqués de Valdecilla

    Santander

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla

  • Hospital de Terrassa

    Terrassa

  • Instituto Valenciano de Oncología

    Valencia, Valencia, 46009

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

  • Hospital La Fe

    Valencia, Valencia, 46026

  • Hospital Álvaro Cunqueiro

    Vigo, Pontevedra

Other trials in Spain

Turkey (Türkiye)4 sites

  • Ankara Oncology Training and Research Hospital

    Ankara, Anadolu Bölgesi, 06200

  • Ankara City Hospital

    Ankara, Anadolu Bölgesi, 06800

  • Hacettepe University

    Ankara, Anadolu Bölgesi, 06800

  • Acibadem Maslak Hospital

    Istanbul, Sarıyer, 34457

Other trials in Turkey (Türkiye)

About this study

Official title: 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)

Being tested
No Further Treatment, TSR-042
Keywords
TSR-042, Anti-PD1, advanced cervical cancer
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.

  • No Further TreatmentOther

    No further treatment

  • TSR-042Drug

    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

Study groups in NCT03833479
Study groupRoleWhat they receive
No further treatmentExperimentalNo further treatment
Receives: Other: No Further Treatment
TSR-042ExperimentalTSR-042 treatment administered using a 30 -minute IV infusion (with a -5 minute and +15 minute window permitted).
Receives: Drug: TSR-042

What is being measured

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

  1. Progression Free Survival

    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)

    Measured: 30 months

Secondary outcomes (6)

  1. Frequency and severity of adverse events (AEs)

    Incidence, nature and severity of adverse events (AEs) assessed by CTCAE version 4.03

    Measured: 30 months

  2. Overall survival (OS)

    Time from the date of randomization to the date of death due to any cause

    Measured: 30 months

  3. Patient reported outcomes (PROs) of health-related quality of life (HRQOL)

    Mean changes from baseline score assessed by the Functional Assessment of Cancer Therapy-Cervix (FACT-Cx)

    Measured: 30 months

  4. Patient reported outcomes (PROs) of health-related quality of life (HRQOL)

    Mean changes from baseline score assessed by EQ -5D-5L.

    Measured: 30 months

  5. Patient reported outcomes (PROs) of fatigue

    Mean changes from baseline score assessed by the PROMIS-Cancer-Fatigue Short Form 4a.

    Measured: 30 months

  6. Patient reported outcomes (PROs) of pain

    Mean changes from baseline score assessed by a single item of the Brief Pain Inventory (BPI).

    Measured: 30 months

Timeline

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

  1. First posted7 Feb 2019
  2. Study start28 Jun 2019
  3. Primary completion31 Jul 2028 (estimated)
  4. Study completion31 Jul 2028 (estimated)

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
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
134 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03833479
Sponsor's protocol ID
GEICO 78-C (ATOMICC)
Other IDs
2023-510268-11-00, 2018-002155-15, 2018, 2023
Acronym
ATOMICC
Status last verified
Jun 2026
First submitted
1 Feb 2019
Last updated
17 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Garcia-Duran C, Grau F, Villacampa G, Oaknin A. ATOMICC trial: a randomized, open-label, phase II trial of anti-PD1, dostarlimab, as maintenance therapy for patients with high-risk locally advanced cervical cancer after chemoradiation. Int J Gynecol Cancer. 2022 Sep 6;32(9):1196-1200. doi: 10.1136/ijgc-2022-003370.

    PubMed 35444013

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing No Further Treatment and TSR-042 in people with Cervical Cancer and Advanced Cancer, run by Grupo Español de Investigación en Cáncer de Ovario at 29 sites in 2 countries.

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 27 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Spain, Turkey (Türkiye). 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?

This study is still under way. Results are not available in the source record yet.

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 (time frame: 30 months). 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 NCT03833479, 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 17 Jun 2026.

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