Polska Grupa Onkologii Ginekologicznej
ds. badań klinicznych

    
PARTNERZY
  

Projekty

Projekty

Rak jajnika

Badania trwające     Badania planowane     Badania zakończone

Badania trwające

Badania planowane

ENGOT-ov / GLORIOSA

Randomized, Multicenter, Open-label, Phase 3 Study of Mirvetuximab Soravtansine in Combination With Bevacizumab Versus Bevacizumab Alone as Maintenance Therapy for Patients With FRα-positive Recurrent Platinum-sensitive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancers Who Have Not Progressed After Second Line Platinum-based Chemotherapy Plus Bevacizumab.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT05445778?term=GLORIOSA&cond=Ovarian+Cancer&draw=2&rank=1

ENGOT-ov68/ARTISTRY-7

A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination with Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT05092360?term=ENGOT-ov68%2FARTISTRY-7&cond=Ovarian+Cancer&draw=2&rank=1

ENGOT-ov72/ ROSELLA

A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA).

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT05257408?cond=Relacorilant+in+Combination+With+Nab-Paclitaxel+in+Advanced%2C+Platinum-Resistant%2CHigh-Grade+Epithelial+Ovarian+%2C+Primary+Peritoneal%2C+or+Fallopian-Tube+Cancer&draw=2&rank=1

Badania zakończone

3000-03-005/ENGOT-ov44/FIRST

An Adaptive Randomized Phase 3 Comparison of Standard Platinum Based Treatment versus Platinum And TSR-042 Followed by Niraparib and TSR-042 Maintenance Therapy in Patients With Epithelial Stage III or IV Cancer of the Ovary, Fallopian Tube, or Peritoneum.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03602859?term=3000-03-005&draw=2&rank=1

AGO-OVAR 23 / DUO-O / D081RC00001 / ENGOT-ov46

A Phase III Randomised, Double-Blind, Placebo-Controlled, Multicentre Study of Durvalumab in Combination with Chemotherapy and Bevacizumab, Followed by Maintenance Durvalumab, Bevacizumab and Olaparib in Newly Diagnosed Advanced Ovarian Cancer Patients.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03737643?term=D081RC00001&draw=2&rank=1

ARAVIVE / ENGOT OV66 / GEICO 104-O study

“A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of AVB-S6-500 in Combination with Paclitaxel in Patients with Platinum-Resistant Recurrent Ovarian Cancer study.

Clinical trials: https://www.clinicaltrials.gov/ct2/show/study/NCT04729608?term=aravive&cond=Ovarian+Cancer&draw=2&rank=1

Ośrodki prowadzące badanie:

  1. Państwowy Instytut Badawczy – Narodowy Instytut Onkologii,  ul. Roentgena 5, 02-781 Warszawa
  2. Uniwersyteckie Centrum Kliniczne, Smoluchowskiego 17, 80-214 Gdańsk
  3. Samodzielny Publiczny Szpital Kliniczny nr 2,PUM w Szczecinie, al. Powstańców Wielkopolskich 72, 70-111 Szczecin
  4. Szpitale Pomorskie Sp. z o.o., ul. Powstania Styczniowego 1, 81-519 Gdynia
  5. Wojewódzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Łodzi, ul. Pabianicka 6, 93-513 Łódź

CO-338-087/GOG-3020-ENGOT-ov45/NCRI/ATHENA

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03522246?term=athena&cond=Ovarian+Cancer&draw=2&rank=1

D0816C00014 / ENGOT-ov38 / OReO

A Phase IIIb, Randomised, Double-blind, Placebo-controlled, Multicentre Study of Olaparib Maintenance Retreatment in Patients with Epithelial Ovarian Cancer Previously Treated With a PARPi and Responding to Repeat Platinum Chemotherapy.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03106987?term=OREO&draw=2&rank=1

ENGOT-ov50 / GOG-3029 / INNOVATE-3

Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 200kHz) concomitant with weeklypaclitaxel for the treatment of platinum-resistant ovarian cancer (PROC).

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03940196?term=ENGOT-ov50%2FINNOVATE-3&draw=2&rank=1

ENGOT-ov65/KEYNOTE-B96

Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer ( ENGOT-ov65 /KEYNOTE-B96)

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT05116189?term=ENGOT-ov65%2FKEYNOTE-B96&draw=2&rank=1

Ośrodki prowadzące badanie:

  1. Państwowy Instytut Badawczy – Narodowy Instytut Onkologii,  ul. Roentgena 5, 02-781 Warszawa
  2. Szpital Kliniczny im. ks. Anny Mazowieckiej, ul. Karowa 2, 00-315 Warszawa
  3. Uniwersytecki Szpital Kliniczny w Poznaniu, ul. Szamarzewskiego 84, 60-569 Poznań
  4. Państwowy Instytut Badawczy – Narodowy Instytut Onkologii, Oddział w Gliwicach, ul. Wybrzeże Armii Krajowej 15, 44-102 Gliwice
  5. Uniwersyteckie Centrum Onkologii, ul. Marii Skłodowskiej-Curie 24, 15-276 Białystok
  6. Białostockie Centrum Onkologii, ul. Ogrodowa 12, 15-027 Białystok
  7. Świętokrzyskie Centrum Onkologii, ul. Artwińskiego 3, 25-734 Kielce
  8. Uniwersyteckie Centrum Kliniczne, Smoluchowskiego 17, 80-214 Gdańsk

IMGN853-0416 / GOG-3045 / ENGOT-OV55 / MIRASOL

A Study of Mirvetuximab Soravtansine vs. Investigator’s Choice of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancers With High Folate Receptor-Alpha Expression

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT04209855?term=IMGN853-0416&draw=2&rank=1

MER-XMT-1536-1 / ENGOT-ov67

A Phase 1b/2 First-in-Human, Dose Escalation and Expansion Study of XMT-1536 In Patients with Solid Tumors Likely to Express NaPi2b.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03319628?term=A+Phase+1b%2F2%2C+First-in-Human%2C+Dose+Escalation+and+Expansion+Study+of+XMT-1536+In+Patients+with+Solid+Tumors+Likely+to+Express+NaPi2b&draw=2&rank=1

MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036

Multicenter, Doubled-blinded, Randomized Phase III trial of Paclitaxel and Carboplatin, with/or without Pembrolizumab and with/or without Olaparib in BRCA wild type Advanced Tubo-Ovarian Carcinoma.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03740165?term=ENGOT-ov43%2FMK-7339-001&draw=2&rank=1

YO39523 / IMagyn050/ GOG 3016/ ENGOT ov39

A Phase III, multicenter, randomized study of Atezolizumab Versus Placebo administered in combination with paclitaxel, carboplatin, and bevacizumab for patients with newly‑diagnosed stage III or stage IV ovarian, fallopian tube, or primary peritoneal cancer.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03038100?term=Imagyn050&draw=2&rank=1

Rak szyjki macicy

Badania trwające     Badania planowane     Badania zakończone

Badania trwające

ENGOT-cx19/GEICO: A Phase III, Randomized, Double-blind, Placebo-controlled, Multi-centre, Global Study of Volrustomig in Women With High Risk Locally Advanced Cervical Cancer Who Have Not Progressed Following Platinum-based, Concurrent Chemoradiation Therapy (eVOLVE-Cervical)

Clinical trials: https://clinicaltrials.gov/study/NCT06079671?cond=Cervical%20Cancer&term=eVolve&rank=1

Ośrodki prowadzące badanie:

  • Białostockie Centrum Onkologii, ul. Ogrodowa 12, 15-027 Białystok
  • Gdański Uniwersytet Medyczny, Katedra i Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej, Mariana Smoluchowskiego 17, 80-214 Gdańsk
  • Wielkopolskie Centrum Onkologii, ul. Garbary 15, 61-866 Poznań
  • Centrum Badań Klinicznych JCI, Jagiellońskie Centrum Innowacji Sp. z o.o., Bobrzyńskiego 14, 30 – 348 Kraków

Badania planowane

Umowa w trakcie negocjacji

Badania zakończone

ENGOT-cx12/ SGNTV-003

A Randomized, Open-Label, Phase 3 Trial of Tisotumab Vedotin versus Investigator’s Choice Chemotherapy in Second or Third Line Metastatic or Recurrent Cervical Cancer.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT04697628?term=ENGOT-cx12%2F+SGNTV-003&cond=Cervical+Cancer&draw=2&rank=1

Ośrodki prowadzące badanie:

  1. Białostockie Centrum Onkologii, ul. Ogrodowa 12, 15-027 Białystok

R2810-ONC-1676 / ENGOT CX9 / GEICO 72-C

An Open-Label, Randomized, Phase 3 Clinical Trial of REGN2810 Versus Investigator’s Choice of Chemotherapy in Recurrent or Metastatic Cervical Carcinoma.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03257267?term=R2810-ONC-1676&draw=2&rank=1

Rak trzonu macicy

Badania trwające     Badania planowane     Badania zakończone

Badania trwające

ENGOT-en21 / KRT-232-118: A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

Clinical trials: https://clinicaltrials.gov/study/NCT05797831?cond=Endometrial%20Cancer&term=ENGOT-en21%20%2F%20KRT-232-118&rank=1

Ośrodki prowadzące badanie:

  • Narodowy Instytut Onkologii – Państwowy Instytut Badawczy ,  ul. Roentgena 5, 02-781 Warszawa
  • Uniwersytecki Szpital Kliniczny w Poznaniu, ul. Szamarzewskiego 84, 60-569 Poznań
  • Narodowy Instytut Onkologii – Państwowy Instytut Badawczy, Oddział w Gliwicach, ul. Wybrzeże Armii Krajowej 15, 44-102 Gliwice
  • Białostockie Centrum Onkologii, ul. Ogrodowa 12, 15-027 Białystok
  • Siedleckie Centrum Onkologii, Mazowiecki Szpital Wojewódzki im. Św. Jana Pawła II w Siedlcach Sp. z o.o., ul. Poniatowskiego 2, 08-110 Siedlce
  • Szpitale Pomorskie Sp. z o.o., ul. Powstania Styczniowego 1, 81-519 Gdynia
  • Gdański Uniwersytet Medyczny, Katedra i Klinika Ginekologii, Ginekologii Onkologicznej i Endokrynologii Ginekologicznej, Mariana Smoluchowskiego 17, 80-214 Gdańsk
  • Centrum Badań Klinicznych JCI, Jagiellońskie Centrum Innowacji Sp. z o.o., Bobrzyńskiego 14, 30 – 348 Kraków
  • Dolnośląskie Centrum Onkologii, pl. Hirszfelda 12, 53-413 Wrocław

KEYNOTE-C93/GOG-3064/ENGOT-en15

A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15)

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT05173987?term=KEYNOTE-C93%2FGOG-3064%2FENGOT-en15&cond=Endometrial+Cancer&draw=2&rank=1

Ośrodki prowadzące badanie:

  1. Państwowy Instytut Badawczy – Narodowy Instytut Onkologii,  ul. Roentgena 5, 02-781 Warszawa
  2. Szpital Kliniczny im. ks. Anny Mazowieckiej, ul. Karowa 2, 00-315 Warszawa
  3. Uniwersytecki Szpital Kliniczny w Poznaniu, ul. Szamarzewskiego 84, 60-569 Poznań
  4. Państwowy Instytut Badawczy – Narodowy Instytut Onkologii, Oddział w Gliwicach, ul. Wybrzeże Armii Krajowej 15, 44-102 Gliwice
  5. Białostockie Centrum Onkologii, ul. Ogrodowa 12, 15-027 Białystok
  6. Centrum Onkologii Ziemi Lubelskiej im. św. Jana z Dukli, ul. Doktora Kazimierza Jaczewskiego 7, 20-090 Lublin
  7. Świętokrzyskie Centrum Onkologii, ul. Artwińskiego 3, 25-734 Kielce
  8. Siedleckie Centrum Onkologii, Mazowiecki Szpital Wojewódzki im. Św. Jana Pawła II w Siedlcach Sp. z o.o., ul. Poniatowskiego 2, 08-110 Siedlce

MK-2870-005/ENGOT-en23/GOG-3095: A Phase 3, Randomized, Active-controlled, Open-label, Multicenter Study to Compare the Efficacy and Safety of MK-2870 Monotherapy Versus Treatment of Physician’s Choice in Participants With Endometrial Cancer Who Have Received Prior Platinum-based Chemotherapy and Immunotherapy

Clinical trials: https://clinicaltrials.gov/study/NCT06132958?cond=Endometrial%20Cancer&term=ENGOT-en23%20%2F%20MK-2870-005&rank=1
  • Narodowy Instytut Onkologii – Państwowy Instytut Badawczy ,  ul. Roentgena 5, 02-781 Warszawa
  • Białostockie Centrum Onkologii, ul. Ogrodowa 12, 15-027 Białystok
  • Siedleckie Centrum Onkologii, Mazowiecki Szpital Wojewódzki im. Św. Jana Pawła II w Siedlcach Sp. z o.o., ul. Poniatowskiego 2, 08-110 Siedlce
  • Wielkopolskie Centrum Onkologii, ul. Garbary 15, 61-866 Poznań

Badania planowane

Umowa w trakcie negocjacji

KRT-232-118 ENGOT-en21 A Phase 2/3 Study of Navtemadlin as Maintenance Therapy in Subjects With TP53WT Advanced or Recurrent Endometrial Cancer Who Responded to Chemotherapy

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT05797831?term=KRT-232-118&draw=2&rank=1

Badania zakończone

D9311C00001 / ENGOT-EN10 / DUO-E

A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT04269200?term=D9311C00001&draw=2&rank=1

ENGOT-en6/ GOG 3031

A Phase 3, Randomized, Double-Blind, Multicenter Study of Dostarlimab (TSR-042) plus Carboplatin-Paclitaxel versus Placebo plus Carboplatin-Paclitaxel in Patients with Recurrent or Primary Advanced Endometrial Cancer.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03981796?term=ENGOT-en6%2F+GOG+3031&draw=2&rank=1

KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT04634877?term=KEYNOTE-B21+%2F+ENGOT-en11+%2F+GOG-3053&draw=2&rank=1

MK-7902-001 / E7080-G000-313 / ENGOT-EN9

A Phase 3 Randomized, Open-Label, Trial of Pembrolizumab Plus Lenvatinib Versus Chemotherapy for the First-line Treatment of Persistent, Recurrent or Metastatic Endometrial Carcinoma.

Clinical trials: https://clinicaltrials.gov/ct2/show/NCT03884101?term=MK-7902-001&draw=2&rank=2