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AzTrials

Epithelial Ovarian CancerPhase 3FORWARD INCT02631876

A Study of Mirvetuximab Soravtansine vs. Investigator's Choice of Chemotherapy in Women With Folate Receptor (FR) Alpha Positive Advanced Epithelial Ovarian Cancer (EOC), Primary Peritoneal or Fallopian Tube Cancer

A Phase 3 study testing Mirvetuximab soravtansine, Paclitaxel and Pegylated liposomal doxorubicin in people with Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma, run by ImmunoGen, Inc. at 131 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Mirvetuximab soravtansine, Paclitaxel and Pegylated liposomal doxorubicin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
366 participants
Where
131 sitesin 13 countries
Study dates
2 Mar 2016to Jan 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • Participants must be diagnosed with advanced epithelial ovarian cancer, primary peritoneal cancer or fallopian tube cancer
  • Participants must have folate receptor alpha positive tumor expression as defined in the protocol
  • Participants must have platinum-resistant ovarian cancer, defined as progression within 6 months from completion of a minimum of four cycles of platinum-containing therapy.
  • Participants must have received at least one but no more than three prior systemic treatment regimens and for whom single-agent chemotherapy is appropriate as the next line of treatment
  • Participants must have at least one lesion that meets the definition of measurable disease by RECIST 1.1

Who cannot join

  • Diagnosis of clear cell, low grade ovarian cancer or mixed tumors
  • Participants with primary platinum-refractory disease
  • Serious concurrent illness or clinically relevant active infection as defined in the protocol
  • Prior treatment with mirvetuximab soravtansine
  • Women who are pregnant or breast feeding

Trial locations and contacts

131 sites in 13 countries.

131 sites in 13 countries

United States53 sites

  • The University of New Mexico Comprehensive Cancer Center - Memorial Medical Center

    Albuquerque, New Mexico, 87131

  • Georgia Regents University (GRU)-Medical College of Georgia (MCG) - Cancer Center

    Augusta, Georgia, 30912

  • Texas Oncology-Austin Central

    Austin, Texas, 78731

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • MD Anderson Cancer Center - Cooper Health

    Camden, New Jersey, 08103

  • Hollings Cancer Center

    Charleston, South Carolina, 29425

  • Levine Cancer Institute - Carolinas Medical Center

    Charlotte, North Carolina, 28204

  • Rush University Medical Center

    Chicago, Illinois, 60629

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45267

  • Fairview Hospital, Moll Pavilion Cancer Center

    Cleveland, Ohio, 44111

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • OSU Wexner Medical Center

    Columbus, Ohio, 43210

  • Women's Cancer Care

    Covington, Louisiana, 70433

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Texas Oncology - Fort Worth

    Fort Worth, Texas, 76104

  • Sudarshan Sharma LTD

    Hinsdale, Illinois, 60521

  • Community Health Network, Inc.

    Indianapolis, Indiana, 46184

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Kadlec Clinic Hematology & Oncology

    Kennewick, Washington, 99336

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • UCLA Women's Health Clinical Research Unit - OBGYN

    Los Angeles, California, 90095

  • Norton Cancer Institute

    Louisville, Kentucky, 40241

  • Hillcrest Hospital

    Mayfield, Ohio, 44124

  • Froedtert and Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Ochsner Clinic Foundation

    New Orleans, Louisiana, 70121

  • Laura and Isaac Perlmutter Cancer Center at NYU Langone

    New York, New York, 10016

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Memorial Sloan Kettering Cancer Center and (MSK Monmouth) and ( MSK Westchester)

    New York, New York, 10065

  • Norwalk Hospital/WCHN

    Norwalk, Connecticut, 06856

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Magee - Womens Hospital of UPMC

    Pittsburgh, Pennsylvania, 15213

  • Women & Infants of Rhode Island

    Providence, Rhode Island, 02905

  • Center of Hope

    Reno, Nevada, 89502

  • University of California San Diego Medical Center

    San Diego, California, 92093

  • California Pacific Medical Center

    San Francisco, California, 94118

  • Florida State University College of Medicine

    Sarasota, Florida, 34239

  • WK Physician Network Clinical Research

    Shreveport, Louisiana, 71101

  • Holy Cross Hospital

    Silver Spring, Maryland, 20902

  • Mercy Women's Oncology

    Springfield, Missouri, 65804

  • Overlook Medical Center

    Summit, New Jersey, 07901

  • Arizona Oncology Associates, PC - HAL

    Tempe, Arizona, 85284

  • Texas Oncology - The Woodlands, Gynecologic Oncology

    The Woodlands, Texas, 77380

  • Arizona Oncology Associates, PC - HOPE

    Tucson, Arizona, 85711

  • Oklahoma Cancer Specialists and Research Institute, LLC

    Tulsa, Oklahoma, 74146

  • Texas Oncology-Tyler

    Tyler, Texas, 75702

  • Kaiser Permanente Medical Center

    Vallejo, California, 94589

  • University of Massachusetts Memorial Medical Center

    Worcester, Massachusetts, 01605

Other trials in United States

Spain16 sites

  • Hospital Teresa Herrera (CHUACoruña)

    A Coruña, 15006

  • ICO Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • IOR - Hospital Quiron Dexeus

    Barcelona, 08028

  • Hospital Vall D'Hebron

    Barcelona, 08035

  • Institut Català d'Oncologia - Unitad de Investigación Clínica

    Barcelona, 08908

  • Hospital Reina Sofia

    Córdoba, 14004

  • Onkologikoa

    Donostia / San Sebastian, Gipuzkoa, 20014

  • Complejo Hospitalario Granada

    Granada, 18014

  • Hospital Universitario Gregorio Maranon

    Madrid, 28007

  • MD Anderson Cancer Center - Madrid

    Madrid, 28033

  • Hospital Universitario Ramon Y Cajal

    Madrid, 28034

  • Servicio de Oncología Médica Hospital Universitario La Paz

    Madrid, 28046

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Regional Universitario Malaga - Hospital Materno Infantil de Málaga

    Málaga, 29011

  • Hospital Son Llatzer (HSLL)

    Palma de Mallorca, 07198

  • Instituto Valenciano de Oncologia

    Valencia, 46009

Other trials in Spain

France12 sites

  • Institut de Cancerologie de L'Ouest - site Paul Papin

    Angers, 49055

  • CHRU Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Cochin Hospital

    Paris, 75014

  • Hôpital Croix St-Simon

    Paris, 75020

  • Centre Hospitalier Lyon-Sud

    Pierre-Bénite, 69495

  • Centre Armoricain de radiotherapie, Imagerie Medicale et Oncol

    Plérin, 22190

  • Centre Eugene Marquis

    Rennes, 35042

  • Institut Curie-Hopital Rene Huguenin

    Saint-Cloud, 92210

  • Institut Claudius Regaud

    Toulouse, 31059

  • Institut de Cancerologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

  • Gustave Roussy Institution

    Villejuif, 94800

Other trials in France

United Kingdom11 sites

  • University Hospitals Coventry & Warwickshire NHS Trust, Arden Cancer Centre

    Coventry, CV2 2DX

  • Beatson West of Scotland Cancer Centre

    Glasgow, Scotland, G12 0YN

  • UCL Cancer Institute

    London, England, WC1E 6BT

  • The Christie NHS Foundation Trust

    Manchester, England, M20 4BX

  • Mount Vernon Cancer Centre

    Northwood, HA6 2RN

  • Nottingham University Hospitals NHS Trust - City Hospital

    Nottingham, England, NG5 1PB

  • Peterborough City Hospital

    Peterborough, Great Britain, PE3 9GZ

  • Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital

    Preston, England, PR2 9HT

  • Cancer,Haematology and Physics Directorate, Cancer Centre Royal Stoke University

    Stoke-on-Trent, Staffordshire, ST4 6QG

  • The Royal Marsden NHS Foundation Trust - Royal Marsden Hospital (RMH)

    Sutton, England, SM2 5PT

  • The Royal Wolverhampton Hospitals NHS Trust - New Cross Hospital - GOW

    Wolverhampton, England, WV10 OQP

Other trials in United Kingdom

Canada10 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • Hopital de la CitedelaSante

    Laval, Quebec, H7M 3L9

  • London Health Sciences Centre

    London, Ontario, N6A 4L6

  • Centre hospitalier de l'Université de Montréal

    Montreal, Quebec, H2X 0A9

  • McGill University Health Centre - Glen Site

    Montreal, Quebec, H4A 3J1

  • The Ottawa Hospital Cancer Centre

    Ottawa, Ontario, K1H8L6

  • Sunnybrook Research Institute - Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Italy9 sites

  • Azienda Ospedaliero Universitaria di Bologna Policlinico S. Orsola-Malpighi

    Bologna, 40138

  • Azienda Sanitaria Locale (ASL)

    Brindisi, 72100

  • Azienda Unita Sanitaria Locale di Ravenna

    Faenza, 48018

  • Romagnolo per lo Studio e la Cura dei Tumori IRST-IRCCS - Oncologia medica

    Meldola (FC), 47014

  • Istituto Europeo di Oncologia

    Milan, MI, 20141

  • Ospedale San Raffaele

    Milan, 20132

  • Fondazione IRCCS National Cancer Institute

    Milan, 20133

  • Istituto Nazionale Tumori- G. Pascale

    Naples, 80131

  • Policlinico Universitario Agostino Gemelli

    Roma, 00168

Other trials in Italy

Belgium4 sites

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • AZ Groeninge - Oncology Centre

    Kortrijk, 8500

  • Universitaire Ziekenhuizen (UZ) Leuven-Gasthuisberg

    Leuven, B-3000

  • Centre Hospitalier de l'Ardenne

    Libramont, 6800

Other trials in Belgium

Russia4 sites

  • LLC "VitaMed"

    Moscow, 121309

  • State Budget-Funded Healthcare Institution of Novosibirsk Oblast "Novosibirsk Oblast Oncology Dispensary"

    Novosibirsk, 630108

  • Budget-Funded Healthcare Institution of Omsk Oblast "Clinical Oncology Dispensary"

    Omsk, 644013

  • State Budget Institution of Health "Leningrad Regional Oncologicacal Dispensary"

    Saint Petersburg, 191014

Other trials in Russia

Czechia3 sites

  • Porodnicka A Gynekologicka Klinika

    Hradec Králové, 500 05

  • University Hospital Ostrava

    Ostrava Poruba, 708 52

  • Onkologicke oddeleni Krajske nemocnice T. Bati, a.s., Zlin

    Zlín, 76275

Other trials in Czechia

Serbia3 sites

  • Oncology and Radiology Institute Serbia

    Belgrade, 11 000

  • Oncology Institute Vojvodina

    Kamenitz, 21 204

  • Clinical Centre Nis, Oncology Clinic

    Niš, 18 000

Other trials in Serbia

Switzerland3 sites

  • Hopitaux Universitaires de Geneve

    Geneva, 1205

  • Kantonsspital Winterthur, Medizinische Onkologie

    Winterthur, Canton of Zurich, 8401

  • Kantonsspital

    Winterthur, Canton of Zurich, 8401

Other trials in Switzerland

Ireland2 sites

  • Bon Secours Hospital

    Cork

  • Mater Private Hospital and Mater Misericordiae University Hospital

    Dublin

Other trials in Ireland

Bosnia and Herzegovina1 site

  • University Clinical Center of Republic of Srpska

    Banja Luka, 78 000

Other trials in Bosnia and Herzegovina

About this study

Official title: FORWARD I: A Randomized, Open Label Phase 3 Study to Evaluate the Safety and Efficacy of Mirvetuximab Soravtansine (IMGN853) Versus Investigator's Choice of Chemotherapy in Women With Folate Receptor Alpha Positive Advanced Epithelial Ovarian Cancer, Primary Peritoneal Cancer or Fallopian Tube Cancer

This is a Phase 3, open label, randomized study designed to compare the safety and efficacy of mirvetuximab soravtansine to that of selected single-agent chemotherapy (Investigator's choice) in women with platinum-resistant FR-alpha positive advanced EOC, primary peritoneal cancer and/or fallopian tube cancer.

Read the detailed description

Participants will be randomized to either mirvetuximab soravtansine or investigator's choice chemotherapy.

Being tested
Mirvetuximab soravtansine, Paclitaxel, Pegylated liposomal doxorubicin, Topotecan
Keywords
Epithelial ovarian cancer, Fallopian tube cancer, Primary peritoneal cancer, IMGN853, ADC, Antibody drug conjugate, ImmunoGen, Antibody, Folate receptor alpha, mirvetuximab soravtansine, Phase 3, platinum-resistant, MIRV
Medical subject headings
Carcinoma, Ovarian Epithelial, Fallopian Tube Neoplasms, Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mirvetuximab soravtansineDrug

    Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.

  • PaclitaxelDrug

    Paclitaxel will be administered per dose and schedule specified in the arm.

  • Pegylated liposomal doxorubicinDrug

    Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.

  • TopotecanDrug

    Topotecan will be administered per dose and schedule specified in the arm.

Study groups in NCT02631876
Study groupRoleWhat they receive
Mirvetuximab SoravtansineExperimentalParticipants will receive mirvetuximab soravtansine at 6 milligrams/kilogram (mg/kg) adjusted ideal body weight (AIBW) administered intravenously (IV) on Day 1 of a 3 week cycle. Participants will continue to receive study drug until they experience progressive disease (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (as assessed by the blinded independent review committee [BIRC]), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 86.9 weeks)
Receives: Drug: Mirvetuximab soravtansine
Investigator's Choice (IC) ChemotherapyExperimentalParticipants will receive a dose of IC chemotherapeutic agent calculated using body surface area (BSA). Paclitaxel will be administered at 80 milligrams/square meter (mg/m^2) as a 1-hour IV infusion on Days 1, 8, 15, and 22 of a 4-week cycle; or topotecan will be administered at 4 mg/m^2 over 30 minutes on Days 1, 8, and 15 of a 4-week cycle. Alternatively, topotecan could be administered at 1.25 mg/m^2 over 30 minutes on Days 1 to 5 of a 3-week cycle; or pegylated liposomal doxorubicin will be administered at 40 mg/m^2 as a 1 mg/minute IV infusion on Day 1 of a 4-week cycle. After Cycle 1, if tolerated, pegylated liposomal doxorubicin could be administered as a 1-hour infusion. Participants will continue to receive study drug until they experience PD per RECIST version 1.1 (as assessed by BIRC), experience unacceptable toxicity, or withdraw consent, whichever comes first, or until the sponsor terminate the study. (Maximum exposure: 62.9 weeks)
Receives: Drug: Paclitaxel; Drug: Pegylated liposomal doxorubicin; Drug: Topotecan

What is being measured

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

  1. Progression-Free Survival (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study

    PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the sum of the longest diameters (SoD) of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

  2. PFS, as Assessed by BIRC Per RECIST Version 1.1 in Participants With High Folate Receptor Alpha Level (≥ 75% of Tumor Staining)

    PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

Secondary outcomes (9)

  1. Objective Response Rate (ORR): Percentage of Participants With Objective Response, as Assessed by BIRC Per RECIST1.1

    ORR was defined as percentage of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). CR: Disappearance of all target or non-target lesions. All pathological or non-pathological lymph nodes (whether target or non-target) must have reduction in short axis to less than (<) 10 millimeters (mm). PR: At least 30 percent (%) decrease in the SoD of target lesions, taking as reference the baseline SoD.

    Measured: From randomization until first BOR of CR or PR (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

  2. Overall Survival (OS)

    OS was defined as the time from the date of randomization until the date of death from any cause. Participants who did not experience the event of death were censored at their last date known to be alive. OS was estimated using the Kaplan-Meier method.

    Measured: From the date of randomization until the time of death (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

  3. Number of Participants Achieving at Least a 15% (≥ 15-Point) Absolute Improvement From Baseline on the EORTC QLQ-OV28 Abdominal/Gastrointestinal (AB/GI) Symptom Subscale at Week 8/9 Assessment

    European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Ovarian Cancer 28 (EORTC QLQ-OV28) is a 28-item ovarian cancer supplemental module. It comprises of 6 symptom scales (AB/GI symptoms, peripheral neuropathy, other chemotherapy side-effects, hormonal symptoms, body image, attitude to disease, treatment), and sexual functioning. Participants were asked to indicate extent to which they experienced AB/GI symptoms. Participants responded on a scale of 1-4(1=not at all, 2=a little, 3=quite a bit, 4=very much) to following: Did you have abdominal pain? Did you have a bloated feeling in your abdomen? Did you have problems with your clothes feeling too tight? Did you experience any change in bowel habit as a result of your disease or treatment? Were you troubled by passing wind/gas/flatulence? Have you felt full too quickly after beginning to eat? Have you had indigestion/heartburn? Data were transformed to a scale from 0-100. Lower scores=better health.

    Measured: Baseline, Week 8/9

  4. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Adverse event (AE): any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to study drug. Severity: graded per National Cancer Institute (NCI) Common Terminology Criteria for AEs (CTCAE) v4.03 on following scale: Grade 1=mild, Grade 2=moderate, Grade 3=severe, Grade 4=life-threatening, Grade 5=death. Relation of AE to treatment was determined by investigator. Serious AEs: death, life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent/significant disability or incapacity, congenital anomaly or birth defect, or an important medical event that required medical intervention to prevent 1 of the outcomes listed in this definition. TEAEs: any AE that emerged on or after the first dose, and within 30 days of the last dose. A summary of serious and all other non-serious AEs regardless of causality is located in the Reported AEs module.

    Measured: From first dose of study drug up to 30 days after last dose of study drug (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

  5. Gynecologic Cancer Intergroup (GCIG) CA-125 Response Rate: Percentage of Participants With GCIG CA-125 Confirmed Clinical Responses

    CA-125 Response rate wasdefined as the number of participants with a CA-125 confirmed response divided by the number of participants in the CA-125 response-evaluable population multiplied by 100.

    Measured: From first dose of study drug until CA-125 response (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

  6. PFS, as Assessed by Investigator Per RECIST Version 1.1

    PFS was defined as the time from randomization until PD or death whichever occurred first, estimated using the Kaplan-Meier method. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions and appearance of new lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.

    Measured: From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

  7. Duration of Response (DOR), as Assessed by BIRC Per RECIST v1.1

    DOR was defined as the time from the date of the first response (CR or PR), whichever was recorded first, until the date of PD. PD: At least a 20% increase in the SoD of target lesion, taken as reference the smallest (nadir) SoD since and including baseline. In addition to the relative increase of 20%, the SoD must also demonstrate an absolute increase of at least 5 mm. Unequivocal progression of non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase. DOR was only defined for participants who had a BOR of CR or PR using the method of Kaplan-Meier.

    Measured: From the date of first response (CR or PR) until the date of PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)

  8. Area Under the Plasma Concentration-Versus Time Curve From Time of Dose Until Tlast (AUClast) of Mirvetuximab Soravtansine,Total M9346A Antibody, DM4, and S-methyl DM4

    PK parameters were calculated using standard non-compartmental methods.

    Measured: Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1 and 3; and Day 8 and 15 of Cycles 1 and 3

  9. Number of Participants With Anti-Drug Antibodies (ADA)

    An electrochemiluminescent method was used for the detection of anti-mirvetuximab soravtansine antibodies in plasma from samples collected in dipotassium ethylenediaminetetraacetic acid (K2EDTA) tubes. The qualitative assay was designed to detect anti-mirvetuximab soravtansine antibodies in human plasma.

    Measured: Pre-dose and within 5 minutes after mirvetuximab soravtansine infusion on Day 1 of Cycles 1, 2, and 4; pre-dose on Day 1 of Cycle 6

Timeline

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

  1. First posted16 Dec 2015 (estimated)
  2. Study start2 Mar 2016
  3. Primary completionJan 2019
  4. Study completionJan 2020

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
366 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02631876
Sponsor's protocol ID
IMGN853-0403
Acronym
FORWARD I
Status last verified
Sep 2020
First submitted
10 Dec 2015
Last updated
14 Oct 2020
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Moore KN, Oza AM, Colombo N, Oaknin A, Scambia G, Lorusso D, Konecny GE, Banerjee S, Murphy CG, Tanyi JL, Hirte H, Konner JA, Lim PC, Prasad-Hayes M, Monk BJ, Pautier P, Wang J, Berkenblit A, Vergote I, Birrer MJ. Phase III, randomized trial of mirvetuximab soravtansine versus chemotherapy in patients with platinum-resistant ovarian cancer: primary analysis of FORWARD I. Ann Oncol. 2021 Jun;32(6):757-765. doi: 10.1016/j.annonc.2021.02.017. Epub 2021 Mar 2.

    PubMed 33667670

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mirvetuximab soravtansine, Paclitaxel and Pegylated liposomal doxorubicin in people with Epithelial Ovarian Cancer and Primary Peritoneal Carcinoma, run by ImmunoGen, Inc. at 131 sites in 13 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 5 inclusion and 5 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: finished, as of the sponsor's last update on 14 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, Spain, France, United Kingdom, Canada and 8 more countries. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 (PFS), as Assessed by BIRC Per RECIST Version 1.1 in All Participants Randomized to the Study (time frame: From the date of randomization until the time of death or PD (maximum exposure: 86.9 weeks for mirvetuximab soravtansine arm and 62.9 weeks for IC chemotherapy arm)). The study lists 2 primary outcomes in all. 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 NCT02631876, 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 14 Oct 2020.

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