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A Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04931342
Recruitment Status : Recruiting
First Posted : June 18, 2021
Last Update Posted : December 20, 2021
Sponsor:
Collaborators:
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This study will evaluate the efficacy and safety of multiple biomarker-driven treatments in patients with persistent or recurrent rare epithelial ovarian, fallopian tube, or primary peritoneal tumors. Enrollment will take place in two phases: a preliminary phase followed by a potential expansion phase.

Condition or disease Intervention/treatment Phase
Ovarian Cancer Drug: Ipatasertib Drug: Cobimetinib Drug: Trastuzumab Emtansine Drug: Atezolizumab Drug: Bevacizumab Drug: Paclitaxel Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II, Open-Label, Multicenter, Platform Study Evaluating the Efficacy and Safety of Biomarker-Driven Therapies in Patients With Persistent or Recurrent Rare Epithelial Ovarian Tumors
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : August 15, 2024
Estimated Study Completion Date : March 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Experimental: Ipatasertib + Paclitaxel
Participants in the Ipatasertib + Paclitaxel arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Drug: Ipatasertib
Ipatasertib 400 mg will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
Other Name: RO5532961

Drug: Paclitaxel
Paclitaxel will be administered intravenously at a dose of 80 mg/m2 on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)

Experimental: Cobimetinib
Participants in the Cobimetinib arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Drug: Cobimetinib
Cobimetinib will be administered by mouth at a dose of 60 mg once a day on Days 1-21 of each cycle. (Cycle length=28 days)
Other Name: RO5514041

Experimental: Trastuzumab Emtansine
Participants in the Trastuzumab Emtansine arm will receive treatment until unacceptable toxicity or disease progression per RECIST v1.1.
Drug: Trastuzumab Emtansine
Trastuzumab Emtansine will be administered intravenously at a dose of 3.6 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
Other Name: RO5304020

Experimental: Atezolizumab + Bevacizumab
Participants in the Atezolizumab + Bevacizumab arm will receive treatment until unacceptable toxicity or loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status.
Drug: Atezolizumab
Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each cycle. (Cycle length=21 days)
Other Name: RO5541267, Tecentriq

Drug: Bevacizumab
Bevacizumab will be administered intravenously at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
Other Name: RO4876646, Avastin




Primary Outcome Measures :
  1. Confirmed Objective Response Rate (ORR) [ Time Frame: Up to approximately 5 years ]
    Confirmed ORR is defined as the proportion of participants with a confirmed complete response (CR) or partial response (PR) (demonstrated on two consecutive occasions >=4 weeks apart), as determined by the investigator according to RECIST v1.1.


Secondary Outcome Measures :
  1. Duration of Response (DOR) [ Time Frame: Up to approximately 5 years ]
    DOR is defined as the time from the first occurrence of a documented objective response to disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

  2. Disease Contral Rate (DCR) [ Time Frame: Up to approximately 5 years ]
    DCR is defined as the proportion of participants with a confirmed CR or PR, or stable disease maintained for at least 16 weeks, as determined by the investigator according to RECIST v1.1.

  3. Progression Free Survival (PFS) [ Time Frame: Up to approximately 5 years ]
    PFS after start of treatment is defined as the time from start of treatment to the first occurrence of disease progression or death from any cause (whichever occurs first), as determined by the investigator according to RECIST v1.1.

  4. Overall Survival (OS) [ Time Frame: Up to approximately 5 years ]
    OS after start of treatment is defined as the time from start of treatment to death from any cause.

  5. Confirmed ORR as Determined by IRC (Independent Review Committee) [ Time Frame: Up to approximately 5 years ]
    Confirmed ORR, as determined by the IRC according to RECIST v1.1.

  6. DOR as Determined by IRC [ Time Frame: Up to approximately 5 years ]
    DOR, as determined by the IRC according to RECIST v1.1

  7. DCR as Determined by IRC [ Time Frame: Up to approximately 5 years ]
    DCR, as determined by the IRC according to RECIST v1.1

  8. PFS as Determined by IRC [ Time Frame: Up to approximately 5 years ]
    PFS, as determined by the IRC according to RECIST v1.1

  9. Percentage of Participants With Adverse Events [ Time Frame: Up to approximately 5 years ]
    Percentage of participants with adverse events.

  10. Percentage of Participants With ADA-Positive and ADA-Negative to Atezolizumab [ Time Frame: At baseline and after baseline (up to approximately 5 years) ]
  11. Number of Participants With ADA-Positive and ADA-Negative to Atezolizumab [ Time Frame: At baseline and after baseline (up to approximately 5 years) ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Persistent or recurrent EOC that meets the following criteria: Histologically confirmed non-high-grade serous, non-high-grade endometrioid epithelial ovarian, fallopian tube, or primary peritoneal cancer (i.e., low-grade serous ovarian carcinoma, clear cell carcinoma, mucinous carcinoma, carcinosarcoma, undifferentiated carcinoma, seromucinous carcinoma, malignant Brenner tumors, Grades 1 or 2 endometrioid carcinoma, or small cell carcinoma of the ovary-hypercalcemic type); Disease that is not amenable to curative surgery
  • Measurable disease (at least one target lesion) according to RECIST v1.1
  • Previous treatment with one to four lines of therapy, at least one of which was platinum-based
  • Platinum-resistant disease (disease progression within 6 months of last platinum therapy)
  • Submission of a representative tumor specimen that is suitable for central molecular analysis (for mandatory NGS testing to determine treatment arm assignment)
  • Submission of stained pathology slides, along with the associated pathology report (for central pathology review)
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
  • Adequate hematologic and end-organ function
  • Female of childbearing potential must be willing to comply with adequate contraception
  • In addition to the general inclusion criteria above, participants must meet all of the arm-specific inclusion criteria for the respective arm

General Exclusion Criteria:

  • Pregnant or breastfeeding, or intending to become pregnant or breastfeed during the study
  • Primary platinum-refractory disease, defined as progression during or within 4 weeks after the last dose of the first-line platinum treatment
  • Histologic diagnosis of high-grade serous or high-grade endometrioid ovarian, fallopian tube, or primary peritoneal cancer
  • Current diagnosis of solely borderline epithelial ovarian tumor
  • Current diagnosis of non-epithelial ovarian tumors
  • Current diagnosis of synchronous primary endometrial cancer
  • Prior history of primary endometrial cancer, with the following exception: a prior diagnosis of primary endometrial cancer is permitted if it meets all of the following conditions: Stage IA, no lymphovascular invasion, International Federation of Gynecology and Obstetrics Grade 1 or 2, not a high-grade subtype.
  • Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  • Symptomatic, untreated, or actively progressing CNS metastases
  • Severe infection within 4 weeks prior to initiation of study treatment
  • Treatment with chemotherapy, radiotherapy, antibody therapy or other immunotherapy, gene therapy, vaccine therapy, or investigational therapy within 28 days prior to initiation of study treatment
  • Treatment with hormonal therapy within 14 days prior to initiation of study treatment
  • In addition to the general exclusion criteria above, participants must meet all of the arm-specific exclusion criteria for the respective arm

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04931342


Contacts
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Contact: Reference Study ID Number: WO42178 https://forpatients.roche.com/ 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 42 study locations
Sponsors and Collaborators
Hoffmann-La Roche
GOG Foundation
European Network of Gynaecological Oncological Trial Groups (ENGOT)
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT04931342    
Other Study ID Numbers: WO42178
GOG-3051 ( Other Identifier: GOG Foundation )
ENGOT-GYN2 ( Other Identifier: European Network of Gynaecological Oncological Trial Groups (ENGOT) )
First Posted: June 18, 2021    Key Record Dates
Last Update Posted: December 20, 2021
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Paclitaxel
Maytansine
Ado-Trastuzumab Emtansine
Bevacizumab
Trastuzumab
Atezolizumab
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors