PankoMab-GEX™ Versus Placebo as Maintenance Therapy in Advanced Ovarian Cancer

NCT01899599 | Completed Phase 2 DMC

• 2 other identifiers: GEXMab252012013-000931-28
• Study Type: interventional
• Target: 216
• Locations: 8 countries
• Sites: 50

Brief Summary

Efficacy of PankoMab-GEX vs Placebo in maintaining a response to chemotherapy in advanced ovarian, fallopian tube or primary peritoneal cancer.

Conditions

Ovarian Epithelial Cancer Recurrent; Fallopian Tube Cancer; Primary Peritoneal Cancer

Keywords

Ovarian Cancer; Maintenance Therapy

Outcome Measures

Primary Outcomes (1)

• Progression free survival

  PFS will be determined by radiographic progression based on modified RECIST 1.1 or death of any cause.

  from baseline till progression of disease or death

Secondary Outcomes (2)

• To assess the safety and tolerability of maintenance therapy with single-agent PankoMab-GEX™ compared to placebo in patients with metastatic or recurrent ovarian or fallopian tube carcinoma or primary peritoneal carcinoma.

  from randomization until end of treatment

• Patient reported outcome

  from randomization until end of treatment

Study Arms (2)

PankoMab-GEX

EXPERIMENTAL

1700mg, i.v., q3w

Drug: PankoMab-GEX

Placebo

PLACEBO COMPARATOR

matching placebo

Drug: Placebo

Interventions

PankoMab-GEX DRUG

start dose 500mg at C0D1, maintenance dose 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.

Also known as: Gatipotuzumab

PankoMab-GEX

Placebo DRUG

start dose matching 500mg at C0D1, maintenance dose matching 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients ≥18 years of age
• Histologically-confirmed, TA-MUC1-positive, recurrent epithelial ovarian, or fallopian-tube cancer or primary peritoneal cancer with high-grade (Grade 2 or 3) serous features or a serous component
• Availability of tumor tissue samples (slices or block) for immune-histological confirmation of TA-MUC1 status (tissue samples could also be stored for other further specified biomarker assessments)
• Patients were to have received at least 2 lines but not more than 5 lines of chemotherapy prior to start of maintenance treatment; neo-adjuvant lines did not count as previous lines of treatment
• Patients had to have a documented response to or SD following the most recent line of chemotherapy (any regimen and duration in accordance with local or international guidelines or within IEC-approved studies) and received the last dose of said chemotherapy ≤6 weeks prior to randomization (response to prior chemotherapy was defined as a PR/CR according to radiological response criteria and/or a confirmed decline in tumor marker CA125 ≥50% from the pre-treatment value for patients who had a pre-treatment value ≥2 x the upper limit of normal \[ULN\]; SD was defined as stable disease according to radiological response criteria with a confirmed lack of increase in tumor marker CA125 from the pre-treatment value for patients who had a pre-treatment value ≥2 × ULN and no clinical progression). Prior to randomization, CA125 had to be below the ULN, or CA125 levels were not to increase \>15% within a time frame \>7 days if above the ULN
• Progression-free interval of ≤12 months immediately preceding the chemotherapy to which the patient had just responded
• Sensitive or resistant to the most recent platinum-based chemotherapy preceding the chemotherapy to which the patient had just responded (sensitivity was thereby defined as a recurrence of disease \>6 to ≤12 months after the end of platinum-based chemotherapy, and resistantance was defined as a recurrence of disease ≤6 months after the end of the platinum-based chemotherapy)
• Eastern Cooperative Oncology Group (ECOG) performance status ≤1
• Recovered from all chemotherapy-related toxicities to Grade 1 or Grade 0 according to the NCI-CTCAE Version 4.0, with the exception of alopecia (any grade) and peripheral neuropathy (≤Grade 2)
• Adequate bone marrow and hepatic function at Screening:
• Hemoglobin ≥9 g/dL
• White blood cell count ≥3.0 × 109/L
• Absolute neutrophil count ≥1.5 × 109/L- Platelet count ≥100 × 109/L
• Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) \<3 × ULN (\<5 × ULN in case of liver metastases)
• Bilirubin \<1.5 × ULN (\<3 × ULN in case of liver metastases)

You may not qualify if:

• Refractory to platinum-based chemotherapy (defined as remained progressive or became progressive under any previous platinum-based regimen)
• Progression-free interval of \>12 months after the most recent antecedent platinum-based chemotherapy regimen
• Concomitant anti-tumor therapy or immunotherapy
• Treatment with monoclonal antibodies or investigational agents ≤30 days before randomization (prior anti-MUC1 therapy was not permitted at any time)
• Limited-field radiotherapy ≤30 days before randomization (extensive prior radiotherapy during or following the last line of chemotherapy was not permitted; radiotherapy prior to the last line of chemotherapy was permitted)
• Prior allergic reaction to a monoclonal antibody, Grade 3 IRR or any Grade 4 reaction to a monoclonal antibody
• Known sensitivity to any component of the test product
• Contraindication to the pre-medication used in this study (paracetamol/acetaminophen, H1 and/or H2 receptor antagonists, or steroids)
• Clinical evidence of brain metastasis or leptomeningeal involvement
• Patients with second primary cancer, except adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, ductal carcinoma in situ, Stage 1 Grade 1 endometrial carcinoma, or other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for ≥5 years
• Primary or secondary immune deficiency
• Clinically active infections \>Grade 2 using NCI-CTCAE version 4.0
• Active hepatitis B or C or infection with human immunodeficiency virus (HIV)
• Myocardial infarction within 6 months prior to Screening
• Symptomatic congestive heart failure (New York Heart Association Grade 3 or 4), unstable angina pectoris within 6 months prior to Screening, significant cardiac arrhythmia or history of stroke or transient ischemic attack within 1 year prior to Screening

Sponsors & Collaborators

• Glycotope GmbH: lead

Study Sites (50)

Investigator

Berlin, 13353, Germany

Location

Investigator

Kiel, 24103, Germany

Location

Investigator

Munich, 80337, Germany

Location

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Munich, 81675, Germany

Location

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Regensburg, 91054, Germany

Location

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Stuttgart, 70376, Germany

Location

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Budapest, 1088, Hungary

Location

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Debrecen, 4035, Hungary

Location

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Szeged, 6720, Hungary

Location

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Meldola, 47014, Italy

Location

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Milan, 20133, Italy

Location

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Milan, 20141, Italy

Location

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Rome, 00168, Italy

Location

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Bydgoszcz, 85796, Poland

Location

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Gdansk, 80402, Poland

Location

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Lublin, 20090, Poland

Location

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Olsztyn, 10513, Poland

Location

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Poznan, 60569, Poland

Location

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Rzeszów, 35242, Poland

Location

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Brasov, 500091, Romania

Location

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Bucharest, 010825, Romania

Location

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Cluj-Napoca, 400015, Romania

Location

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Cluj-Napoca, 400058, Romania

Location

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Craiova, 200347, Romania

Location

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Oradea, 410469, Romania

Location

Investigator

Timișoara, 300167, Romania

Location

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Timișoara, 300239, Romania

Location

Investigator

Kazan', 450029, Russia

Location

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Moscow, 111123, Russia

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Moscow, 115478, Russia

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Moscow, 129128, Russia

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Oryol, 302020, Russia

Location

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Pyatigorsk, 357502, Russia

Location

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Rostov-on-Don, 344037, Russia

Location

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Saint Petersburg, 188663, Russia

Location

Investigator

Saint Petersburg, 197758, Russia

Location

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Saint Petersburg, 198255, Russia

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Volgograd, 404133, Russia

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Investigator

Yaroslavl, 150040, Russia

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Barcelona, 08916, Spain

Location

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Madrid, 28007, Spain

Location

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Madrid, 28040, Spain

Location

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Madrid, 28041, Spain

Location

Investigator

Madrid, 28046, Spain

Location

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Madrid, 28223, Spain

Location

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Valencia, 46009, Spain

Location

Investigator

London, SW3 6JJ, United Kingdom

Location

Investigator

London, W1T 4TJ, United Kingdom

Location

Investigator

Northwood, HA6 2RN, United Kingdom

Location

Investigator

Sutton, SM2 5PT, United Kingdom

Location

Related Publications (1)

• Ledermann JA, Zurawski B, Raspagliesi F, De Giorgi U, Arranz Arija J, Romeo Marin M, Lisyanskaya A, Poka RL, Markowska J, Cebotaru C, Casado Herraez A, Colombo N, Kutarska E, Hall M, Jacobs A, Ahrens-Fath I, Baumeister H, Zurlo A, Sehouli J. Maintenance therapy of patients with recurrent epithelial ovarian carcinoma with the anti-tumor-associated-mucin-1 antibody gatipotuzumab: results from a double-blind, placebo-controlled, randomized, phase II study. ESMO Open. 2022 Feb;7(1):100311. doi: 10.1016/j.esmoop.2021.100311. Epub 2021 Dec 15.

  PMID: 34920291 DERIVED

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

PankoMab-GEX

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Endocrine Gland Neoplasms; Ovarian Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Jonathan Ledermann, MD

  UCL Cancer Institute, 90 Tottenham Court Road, London W1T 4TJ, UK

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 4, 2013
• First Posted: July 15, 2013
• Study Start: September 1, 2013
• Primary Completion: April 20, 2017
• Study Completion: July 28, 2017
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (7); PL (6); RO (8); RU (12); DE (6); GB (4); HU (3); IT (4)