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| ID | Type | Description | Link |
|---|---|---|---|
| 2023-510268-11-00 | EU Trial (CTIS) Number | ||
| 2018-002155-15 | EudraCT Number |
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| Name | Class |
|---|---|
| Apices Soluciones S.L. | INDUSTRY |
| GSK/TESARO | UNKNOWN |
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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No further treatment | Experimental | No further treatment |
|
| TSR-042 | Experimental | TSR-042 treatment administered using a 30 -minute IV infusion (with a -5 minute and +15 minute window permitted). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| No Further Treatment | Other | No further treatment |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and severity of adverse events (AEs) | Incidence, nature and severity of adverse events (AEs) assessed by CTCAE version 4.03 | 30 months |
| Overall survival (OS) | Time from the date of randomization to the date of death due to any cause |
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Inclusion Criteria:
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.
At diagnosis:
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:
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
Exclusion Criteria:
Female patients
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| Name | Affiliation | Role |
|---|---|---|
| Ana Oaknin, PhD | Hospital Vall d'Hebron | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General Universitario de Elche | Elche | Alicante | Spain | |||
| Hospital Universitario Donostia- Donostia Unibertsitate Ospitalea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35444013 | Derived | 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. |
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| TSR-042 |
| Drug |
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 |
|
| 30 months |
| 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) | 30 months |
| Patient reported outcomes (PROs) of health-related quality of life (HRQOL) | Mean changes from baseline score assessed by EQ -5D-5L. | 30 months |
| Patient reported outcomes (PROs) of fatigue | Mean changes from baseline score assessed by the PROMIS-Cancer-Fatigue Short Form 4a. | 30 months |
| Patient reported outcomes (PROs) of pain | Mean changes from baseline score assessed by a single item of the Brief Pain Inventory (BPI). | 30 months |
| Donostia / San Sebastian |
| Gipuzkoa |
| 20014 |
| Spain |
| ICO Girona | Girona | Girona | 17007 | Spain |
| Hospital Universitario La Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | Spain |
| Hospital Álvaro Cunqueiro | Vigo | Pontevedra | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | Spain |
| Instituto Valenciano de Oncología | Valencia | Valencia | 46009 | Spain |
| Hospital Clínico Universitario de Valencia | Valencia | Valencia | 46010 | Spain |
| Hospital La Fe | Valencia | Valencia | 46026 | Spain |
| H Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Clínic | Barcelona | Spain |
| H Reina Sofía Cordoba | Córdoba | 14004 | Spain |
| ICO Hospitalet | Hospitalet Del Llobregat | Spain |
| Clinica Universitaria de Navarra | Madrid | Spain |
| Hospital Clínico San Carlos | Madrid | Spain |
| Hospital Ramon y Cajal | Madrid | Spain |
| Hospital Virgen de la Victoria | Málaga | Spain |
| Hospital Clinico Universitario Virgen Arrixaca | Murcia | Spain |
| Hospital Universitario Morales Meseguer | Murcia | Spain |
| Hospital Son Espases | Palma de Mallorca | Spain |
| Hospital Son Llatzer | Palma de Mallorca | Spain |
| H. Parc Taulí | Sabadell | 08208 | Spain |
| Hospital Marqués de Valdecilla | Santander | Spain |
| Hospital de Terrassa | Terrassa | Spain |
| Ankara Oncology Training and Research Hospital | Ankara | Anadolu Bölgesi | 06200 | Turkey (Türkiye) |
| Ankara City Hospital | Ankara | Anadolu Bölgesi | 06800 | Turkey (Türkiye) |
| Hacettepe University | Ankara | Anadolu Bölgesi | 06800 | Turkey (Türkiye) |
| Acibadem Maslak Hospital | Istanbul | Sarıyer | 34457 | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| C000719628 | dostarlimab |
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