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A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

Primary Purpose

Ovarian Neoplasms

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Carboplatin

Paclitaxel

oregovomab

About this trial

This is an interventional treatment trial for Ovarian Neoplasms focused on measuring ovarian, cancer, neoplasm, adenocarcinoma, CA125

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage III/IV disease.
have preoperative CA125 levels > 50 U/mL
have optimal cytoreduction (RT<1)
be anticipated to have first-line chemotherapy infusion within 6 weeks after surgery
be available to complete the protocol for the duration of the study
have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/µL, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1. Platelets greater than or equal to 100,000/µL; hemoglobin greater than or equal to 8.0 g/dL
have adequate Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1
have adequate Hepatic function: bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1)
able to sign informed consent and provide authorization permitting release of personal health information
have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis)
have a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or cannot tolerate cyclophosphamide
are being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids.
have a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia
have an acquired, hereditary, or congenital immunodeficiency
have uncontrolled diseases other than cancer
have contraindications to the use of pressor agents
have undergone more than one surgical debulking
have hepatic dysfunction, eg, bilirubin more than 1.5 times higher than normal levels, lactate dehydrogenase (LDH), serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) doubled compared to normal or albumin <3.5 g/dL
have severe renal insufficiency with serum creatinine >1.6 mg/dL
have concomitant diseases or treatments that may confound the results of the study, which may preclude the completion of the protocol or may mask adverse reactions
are to be tested with other medications during treatment
are unable to read or understand or unable to sign the necessary written consent before starting treatment

Sites / Locations

University of Connecticut Health Center
Northern Indiana Cancer Research Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

carboplatin & paclitaxel

carboplatin & paclitaxel & oregovomab

Arm Description

first-line chemotherapy for ovarian cancer

first-line chemotherapy for ovarian cancer plus oregovomab

Outcomes

Primary Outcome Measures

CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy

Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy

Secondary Outcome Measures

Time to clinical relapse

The time period from the date of randomization to the date of confirmed relapse as defined by clinical, radiologic, and/or pathologic evaluations.

Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity)

Laboratory test for human anti-mouse antibody (HAMA) present in patients' sera. DTH (delayed type hypersensitivity) is an on-site test conducted by the investigator by injecting a small amount of the Oregovomab product and three other antigens (mumps, tetanus, and Candida) into the skin of the patient and observing the effects.

Clinical response

Patients will be categorized into one of the following: increasing disease, stable disease, or progression [measurable disease studies]

Overall Survival

The observed length of life from entry into the study to death or the date of last contact

Full Information

NCT ID

NCT01616303

First Posted

May 30, 2012

Last Updated

September 11, 2020

Sponsor

Quest PharmaTech Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01616303

Brief Title

A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

Official Title

Phase 2: A Randomized Controlled Study on Effectiveness of Chemotherapy (Carboplatin-Paclitaxel) Versus Chemo-immunotherapy (Carboplatin-Paclitaxel-Oregovomab) in Patients With Advanced Epithelial Ovarian, Adnexal or Peritoneal Carcinoma

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Completed

Study Start Date

June 15, 2012 (Actual)

Primary Completion Date

June 15, 2015 (Actual)

Study Completion Date

October 12, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Quest PharmaTech Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This is a Phase 2 randomized study with two treatment arms to compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.

Detailed Description

Oregovomab is an investigational drug previously used in clinical trials as an immunotherapeutic treatment of ovarian cancer patients whose tumor cells express the tumor associated antigen, CA125. The active component of oregovomab is the activated murine monoclonal antibody B43.13, an immunoglobulin G1k (IgG1k) subclass immunoglobulin that binds with high affinity (1.16E10/M) to CA125. CA125 is a surface glycoprotein antigen that is expressed on more than 80% of all non-mucinous epithelial ovarian carcinomas where it occurs at elevated levels in the serum of patients with ovarian cancer. Little is known about its biological function. CA125 is associated with a large molecular weight mucin-like glycoprotein complex of 200-250 kilodaltons (kDa) and its genetic structure has recently been elucidated. There is good evidence to suggest that CA125 is a relevant target antigen for antigen-mediated immunotherapy of ovarian cancer. The study will compare the effectiveness of oregovomab (a murine monoclonal antibody directed against cancer antigen 125 (CA125)) when combined with first-line chemotherapy (carboplatin and paclitaxel) to first-line chemotherapy (carboplatin and paclitaxel alone) in female patients with advanced ovarian cancer.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ovarian Neoplasms

Keywords

ovarian, cancer, neoplasm, adenocarcinoma, CA125

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

97 (Actual)

8. Arms, Groups, and Interventions

Arm Title

carboplatin & paclitaxel

Arm Type

Active Comparator

Arm Description

first-line chemotherapy for ovarian cancer

Arm Title

carboplatin & paclitaxel & oregovomab

Arm Type

Experimental

Arm Description

first-line chemotherapy for ovarian cancer plus oregovomab

Intervention Type

Drug

Intervention Name(s)

Carboplatin

Intervention Description

carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days])

Intervention Type

Drug

Intervention Name(s)

Paclitaxel

Intervention Description

Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days])

Intervention Type

Biological

Intervention Name(s)

oregovomab

Other Intervention Name(s)

OvaRex

Intervention Description

oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).

Primary Outcome Measure Information:

Title

CA125 ELISPOT assay response for cytotoxic T cell antigen specific immunity induction to end of first-line chemotherapy

Description

Change from baseline CA125 ELISPOT assay after stimulation with oregovomab (MAb-B43.13 against CA125) measured at approximately 12 weeks and 25 weeks after the start of first-line chemotherapy

Time Frame

At Baseline (up to 4 weeks before Cycle 1), at Cycle 5 (approximately 12 weeks after Cycle 1) and termination (approximately 25 weeks after Cycle 1)

Secondary Outcome Measure Information:

Title

Time to clinical relapse

Description

The time period from the date of randomization to the date of confirmed relapse as defined by clinical, radiologic, and/or pathologic evaluations.

Time Frame

Up to three years after treatment in the study

Title

Immune parameters: HAMA (human anti-mouse antibody) titers and DTH (delayed type hypersensitivity)

Description

Time Frame

Up to three years after treatment in the study

Title

Clinical response

Description

Patients will be categorized into one of the following: increasing disease, stable disease, or progression [measurable disease studies]

Time Frame

Up to three years after treatment in the study

Title

Overall Survival

Description

The observed length of life from entry into the study to death or the date of last contact

Time Frame

Up to three years after treatment in the study

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: have newly diagnosed epithelial adenocarcinoma of ovarian, tubal or peritoneal origin and French Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) Stage III/IV disease. have preoperative CA125 levels > 50 U/mL have optimal cytoreduction (RT<1) be anticipated to have first-line chemotherapy infusion within 6 weeks after surgery be available to complete the protocol for the duration of the study have adequate Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/µL, equivalent to Common Terminology Criteria (CTCAE v3.0) grade 1. Platelets greater than or equal to 100,000/µL; hemoglobin greater than or equal to 8.0 g/dL have adequate Renal function: creatinine less than or equal to 1.5 x institutional upper limit normal (ULN), CTCAE v3.0 grade 1 have adequate Hepatic function: bilirubin less than or equal to 1.5 x ULN (CTCAE v3.0 grade 1). SGOT and alkaline phosphatase less than or equal to 2.5 x ULN (CTCAE v3.0 grade 1) able to sign informed consent and provide authorization permitting release of personal health information have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1 Exclusion Criteria: have an active autoimmune disease (e.g., rheumatoid arthritis, systemic lupus erythematosus (SLE), ulcerative colitis, Crohn's Disease, multiple sclerosis (MS), ankylosing spondylitis) have a known allergy to murine proteins or have had a documented anaphylactic reaction to any drug, or cannot tolerate cyclophosphamide are being chronically treated with immunosuppressive drugs such as cyclosporin, adrenocorticotropic hormone (ACTH), or systemic corticosteroids. have a recognized immunodeficiency disease including cellular immunodeficiencies, hypogammaglobulinemia or dysgammaglobulinemia have an acquired, hereditary, or congenital immunodeficiency have uncontrolled diseases other than cancer have contraindications to the use of pressor agents have undergone more than one surgical debulking have hepatic dysfunction, eg, bilirubin more than 1.5 times higher than normal levels, lactate dehydrogenase (LDH), serum glutamic oxaloacetic transaminase (SGOT) and serum glutamic pyruvic transaminase (SGPT) doubled compared to normal or albumin <3.5 g/dL have severe renal insufficiency with serum creatinine >1.6 mg/dL have concomitant diseases or treatments that may confound the results of the study, which may preclude the completion of the protocol or may mask adverse reactions are to be tested with other medications during treatment are unable to read or understand or unable to sign the necessary written consent before starting treatment

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Thomas Woo, M.Sc.

Organizational Affiliation

Quest PharmaTech Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Christopher Nicodemus, MD FACP

Organizational Affiliation

AIT Strategies

Official's Role

Study Chair

Facility Information:

Facility Name

University of Connecticut Health Center

City

Farmington

State/Province

Connecticut

ZIP/Postal Code

06030

Country

United States

Facility Name

Northern Indiana Cancer Research Consortium

City

South Bend

State/Province

Indiana

ZIP/Postal Code

46601

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

31916979

Citation

Brewer M, Angioli R, Scambia G, Lorusso D, Terranova C, Panici PB, Raspagliesi F, Scollo P, Plotti F, Ferrandina G, Salutari V, Ricci C, Braly P, Holloway R, Method M, Madiyalakan M, Bayever E, Nicodemus C. Front-line chemo-immunotherapy with carboplatin-paclitaxel using oregovomab indirect immunization in advanced ovarian cancer: A randomized phase II study. Gynecol Oncol. 2020 Mar;156(3):523-529. doi: 10.1016/j.ygyno.2019.12.024. Epub 2020 Jan 6.

Results Reference

result

PubMed Identifier

31897661

Citation

Battaglia A, Buzzonetti A, Fossati M, Scambia G, Fattorossi A, Madiyalakan MR, Mahnke YD, Nicodemus C. Translational immune correlates of indirect antibody immunization in a randomized phase II study using scheduled combination therapy with carboplatin/paclitaxel plus oregovomab in ovarian cancer patients. Cancer Immunol Immunother. 2020 Mar;69(3):383-397. doi: 10.1007/s00262-019-02456-z. Epub 2020 Jan 3. Erratum In: Cancer Immunol Immunother. 2020 Jul;69(7):1389.

Results Reference

result

Links:

URL

http://www.questpharmatech.com/

Description

Sponsor website

Learn more about this trial

A Controlled Study of the Effectiveness of Oregovomab (Antibody) Plus Chemotherapy in Advanced Ovarian Cancer

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