This study is NOT currently recruiting participants.
Number
001583-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Completed Study; data analyses ongoing Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
No
Population Exclusion(s)
Pregnant Women;Children
Keywords
Ovarian Cancer; Primary Peritoneum Cancer; Fallopian Tube Cancer; Immunotherapy; IL-2 Immunotherapy; Metastatic Cancer; Human Interleukin 2; Interleukin 2; hIL-2; Encapsulated Cell Therapy
Recruitment Keyword(s)
None
Condition(s)
Neoplasm, Ovarian; Fallopian Tube Cancer; Primary Peritoneal Cavity Cancer; Adenocarcinoma Ovary; Serous Adenocarcinoma of Ovary; Serous Adenocarcinoma of Primary Peritoneum; Primary Peritoneal Carcinoma; High Grade Serous Adenocarcinoma
Investigational Drug(s)
AVB-001
Investigational Device(s)
Intervention(s)
Drug: AVB-001
Supporting Site
National Cancer Institute
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INCLUSION CRITERIA: Patients who meet all of the following criteria will be eligible to participate in the study: 1. Have histologically confirmed, metastatic or unresectable, platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube; Note: For the purposes of this study, platinum-resistant is defined as a patient who has received platinum-containing chemotherapy and either has platinum-refractory disease (progressed during initial platinum-based chemotherapy) or resistant disease (relapsed within 6 months of initial platinum-containing chemotherapy) or, if previously with platinum-sensitive disease, has received at least 2 lines of platinum-containing chemotherapy and progressed. Note: A pathology report confirming histology will be required for enrollment. 2. Have not received more than 5 lines of prior therapy; 3. May have received poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, bevacizumab (or any other antiangiogenic agent), immunotherapy, or cell therapies. (Patients with germline or somatic BRCA mutations must have progressed or been intolerant to PARP inhibitor therapy); 4. Are >=18 years of age; 5. Have an Eastern Cooperative Oncology Group performance status 0 to 1 at Screening; 6. Meet the following laboratory criteria: -Absolute neutrophil count >1500/microliter; -Hemoglobin level >=9.0 g/dL (transfusion allowed); -Platelet count >=100,000/microliter; -Creatinine clearance >=50 mL/minute, measured using the Cockcroft-Gault formula, and serum creatinine <=1.5 x upper limit of normal (ULN); -Alanine aminotransferase (ALT) <=2.5 x ULN, aspartate aminotransferase (AST) <=2.5 x ULN; and total bilirubin <=1.5 x ULN (or <=3 x ULN in cases of Gilbert s syndrome); and -International normalized ratio <1.5 and activated partial thromboplastin time (or partial thromboplastin time) within normal limits per the institution. Note: Patients on direct-acting anticoagulants or other anticoagulation medications are eligible as long as they are able to hold the drug for the laparoscopic procedure on Day 1 per institutional guidance. 7. Have intraperitoneal disease and evidence of measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan as defined by RECIST v1.1; Note: Measurable disease cannot include a lesion that was biopsied. Patients must, at a minimum, have 1 measurable lesion. Note: Patients with IP disease who also have disease involving the pleural cavity or distant metastases will be eligible if they have measurable or evaluable disease in the intraperitoneal cavity. 8. Agree to use a highly effective method of birth control (women of childbearing potential only) as defined in the Protocol; and 9. Are willing and able to provide written informed consent or have a legally authorized representative willing and able to provide informed consent at Screening. EXCLUSION CRITERIA: Patients who meet any of the following criteria will be excluded from participation in the study: 1. Have low-grade serous, mucinous, clear cell, or endometroid adenocarcinoma of the ovary, primary peritoneum, or fallopian tube; carcinosarcoma; or a mixed histology tumor; 2. Have another malignancy or have had a prior malignancy within 3 years prior to the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy, excluding adequately managed with curative-intent treatment for basal cell carcinoma, squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, cervical carcinoma in situ, melanoma in situ, or ductal carcinoma in situ of the breast; 3. Have had a previous solid organ transplantation; 4. Have not recovered from prior clinically significant AEs to Grade <=1 severity per NCI CTCAE v5.0 (except alopecia) due to prior therapy; Note: Stable Grade 2 peripheral neuropathy may be allowed at the discretion of the Investigator. 5. Have persistent autoimmune side effects from prior immune therapies (ie, checkpoint inhibitors). Eligibility for patients with prior severe autoimmune AEs (ie, Grade 3 or 4 [per NCI CTCAE v5.0] immune-related AEs that led to discontinuation of prior immune therapy) will be discussed between the Sponsor and the Investigator on a case-by-case basis. Prior history of severe side effects such as carditis, pneumonitis, encephalitis, hepatitis, or colitis with prior immune therapies will be excluded; 6. Have a chronic or ongoing active infectious disease requiring systemic treatment. Patients with an active infection may become eligible once the infection has resolved and they are at least 14 days from completion of antibiotics or when symptoms have resolved, at the discretion of the Investigator; 7. Have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or received vaccination against SARS-CoV-2 within the 14 days prior to study drug administration OR have tested positive for SARS-CoV-2 and are symptomatic at Screening; Note: A patient who tests positive for SARS-CoV-2 and is asymptomatic may be eligible provided at least 2 weeks have passed between the negative test and study drug administration. The first negative SARS-CoV-2 test should be followed by a confirmatory test 1 week later. However, for patients who have been treated with Paxlovid(TM) or remdesivir, a shorter waiting time may be acceptable. 8. Have a known diagnosis of HIV or hepatitis infection; 9. Have had major surgery <=4 weeks prior to study drug administration or have not fully recovered from a previous surgery based on the judgment of the Investigator; 10. Have received a live vaccination within the 30 days prior to study drug administration; 11. Have a history of autoimmune disease, such as Crohn s disease, scleroderma (excluding endocrine autoimmune disease treated with replacement therapy), or inflammatory diseases (eg, active rheumatoid arthritis, inflammatory bowel disease, myasthenia gravis, crescentic immunoglobulin A glomerulonephritis, cerebral vasculitis, Stevens-Johnson syndrome, or bullous pemphigoid), or are undergoing chronic immunosuppressive therapy (eg, cyclosporine), including therapy with systemic corticosteroids; Note: Physiologic replacement (at a dose of <=10 mg daily of prednisolone [or steroid equivalent]) and use of topical or inhaled corticosteroids are allowed. Intermittent use of steroids as pre-medication is also allowed. 12. Have clinical signs or symptoms of partial or complete gastrointestinal obstruction or active fistula, are at high risk for fistulization as per the Investigator s assessment, or have a history of gastrointestinal bleeding within the past 6 months; 13. Are females who are pregnant or breastfeeding; Note: A urine pregnancy test will be performed at Screening (only in women of childbearing potential). 14. Have diminished pulmonary function defined as Grade >=2 [per NCI CTCAE v5.0] dyspnea and/or peripheral oxygen saturation <92% on room air (measured by pulse oximetry); 15. Have clinically significant cardiac disease defined as follows: -New York Heart Association Class III or IV congestive heart failure; -Left ventricular ejection fraction <45%, measured by echocardiogram or multigated acquisition scan at Screening; -Acute coronary syndrome (eg, angina or myocardial infarction), stroke, or peripheral vascular disease within the last 12 months before Screening; or -Uncontrolled clinically significant arrhythmia. 16. Have an average corrected QTcF outside the normal range per institutional values; 17. Have another significant concurrent, uncontrolled medical condition including, but not limited to, cardiologic, pulmonary, renal, hepatic, hematological, gastrointestinal, endocrine, neurological, cerebral, or psychiatric disease; 18. Have symptomatic or uncontrolled brain metastases (including leptomeningeal involvement) requiring current treatment (4 weeks from last cranial irradiation or <4 weeks from last steroids); Note: Patients with an abnormal clinical examination or history will require a head CT or MRI to rule out or confirm brain metastases. 19. Have a known or suspected allergy to AVB-001 or known or suspected allergy to any components of AVB-001, including alginate or seaweed; 20. Have received at least 1 of the following approved cancer treatments prior to study drug administration: -Immunomodulatory therapy within 7 days (excluding immune checkpoint inhibitors, as described below); -Small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is shorter; -Endocrine therapy within 14 days (including tamoxifen, aromatase inhibitor, high-potency progesterone, and gonadotropin-releasing hormone analogue, etc); -Radiotherapy within 14 days; -Cytotoxic therapy within 21 days; -Monoclonal antibody therapy within 21 days; -Immunotherapy with an immune checkpoint inhibitor within 6 weeks; -Other novel forms of interleukin (IL)-2 or IL-2-like molecules at any time point; or -IP gene-targeted therapy at any time point. 21. Have any condition that, in the opinion of the Investigator, would lead to the inability of the patient to comply with the Protocol.
Patients who meet all of the following criteria will be eligible to participate in the study:
1. Have histologically confirmed, metastatic or unresectable, platinum-resistant, high-grade, serous adenocarcinoma of the ovary, primary peritoneum, or fallopian tube;
Note: For the purposes of this study, platinum-resistant is defined as a patient who has received platinum-containing chemotherapy and either has platinum-refractory disease (progressed during initial platinum-based chemotherapy) or resistant disease (relapsed within 6 months of initial platinum-containing chemotherapy) or, if previously with platinum-sensitive disease, has received at least 2 lines of platinum-containing chemotherapy and progressed.
Note: A pathology report confirming histology will be required for enrollment.
2. Have not received more than 5 lines of prior therapy;
3. May have received poly adenosine diphosphate-ribose polymerase (PARP) inhibitors, bevacizumab (or any other antiangiogenic agent), immunotherapy, or cell therapies. (Patients with germline or somatic BRCA mutations must have progressed or been intolerant to PARP inhibitor therapy);
4. Are >=18 years of age;
5. Have an Eastern Cooperative Oncology Group performance status 0 to 1 at Screening;
6. Meet the following laboratory criteria:
-Absolute neutrophil count >1500/microliter;
-Hemoglobin level >=9.0 g/dL (transfusion allowed);
-Platelet count >=100,000/microliter;
-Creatinine clearance >=50 mL/minute, measured using the Cockcroft-Gault formula, and serum creatinine <=1.5 x upper limit of normal (ULN);
-Alanine aminotransferase (ALT) <=2.5 x ULN, aspartate aminotransferase (AST) <=2.5 x ULN; and total bilirubin <=1.5 x ULN (or <=3 x ULN in cases of Gilbert s syndrome); and
-International normalized ratio <1.5 and activated partial thromboplastin time (or partial thromboplastin time) within normal limits per the institution.
Note: Patients on direct-acting anticoagulants or other anticoagulation medications are eligible as long as they are able to hold the drug for the laparoscopic procedure on Day 1 per institutional guidance.
7. Have intraperitoneal disease and evidence of measurable disease on computed tomography (CT) or magnetic resonance imaging (MRI) scan as defined by RECIST v1.1;
Note: Measurable disease cannot include a lesion that was biopsied. Patients must, at a minimum, have 1 measurable lesion.
Note: Patients with IP disease who also have disease involving the pleural cavity or distant metastases will be eligible if they have measurable or evaluable disease in the intraperitoneal cavity.
8. Agree to use a highly effective method of birth control (women of childbearing potential only) as defined in the Protocol; and
9. Are willing and able to provide written informed consent or have a legally authorized representative willing and able to provide informed consent at Screening.
EXCLUSION CRITERIA:
Patients who meet any of the following criteria will be excluded from participation in the study:
1. Have low-grade serous, mucinous, clear cell, or endometroid adenocarcinoma of the ovary, primary peritoneum, or fallopian tube; carcinosarcoma; or a mixed histology tumor;
2. Have another malignancy or have had a prior malignancy within 3 years prior to the first dose of study drug or any evidence of residual disease from a previously diagnosed malignancy, excluding adequately managed with curative-intent treatment for basal cell carcinoma, squamous cell carcinoma of the skin, cervical intraepithelial neoplasia, cervical carcinoma in situ, melanoma in situ, or ductal carcinoma in situ of the breast;
3. Have had a previous solid organ transplantation;
4. Have not recovered from prior clinically significant AEs to Grade <=1 severity per NCI CTCAE v5.0 (except alopecia) due to prior therapy;
Note: Stable Grade 2 peripheral neuropathy may be allowed at the discretion of the Investigator.
5. Have persistent autoimmune side effects from prior immune therapies (ie, checkpoint inhibitors). Eligibility for patients with prior severe autoimmune AEs (ie, Grade 3 or 4 [per NCI CTCAE v5.0] immune-related AEs that led to discontinuation of prior immune therapy) will be discussed between the Sponsor and the Investigator on a case-by-case basis. Prior history of severe side effects such as carditis, pneumonitis, encephalitis, hepatitis, or colitis with prior immune therapies will be excluded;
6. Have a chronic or ongoing active infectious disease requiring systemic treatment. Patients with an active infection may become eligible once the infection has resolved and they are at least 14 days from completion of antibiotics or when symptoms have resolved, at the discretion of the Investigator;
7. Have tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) or received vaccination against SARS-CoV-2 within the 14 days prior to study drug administration OR have tested positive for SARS-CoV-2 and are symptomatic at Screening;
Note: A patient who tests positive for SARS-CoV-2 and is asymptomatic may be eligible provided at least 2 weeks have passed between the negative test and study drug administration. The first negative SARS-CoV-2 test should be followed by a confirmatory test 1 week later. However, for patients who have been treated with Paxlovid(TM) or remdesivir, a shorter waiting time may be acceptable.
8. Have a known diagnosis of HIV or hepatitis infection;
9. Have had major surgery <=4 weeks prior to study drug administration or have not fully recovered from a previous surgery based on the judgment of the Investigator;
10. Have received a live vaccination within the 30 days prior to study drug administration;
11. Have a history of autoimmune disease, such as Crohn s disease, scleroderma (excluding endocrine autoimmune disease treated with replacement therapy), or inflammatory diseases (eg, active rheumatoid arthritis, inflammatory bowel disease, myasthenia gravis, crescentic immunoglobulin A glomerulonephritis, cerebral vasculitis, Stevens-Johnson syndrome, or bullous pemphigoid), or are undergoing chronic immunosuppressive therapy (eg, cyclosporine), including therapy with systemic corticosteroids;
Note: Physiologic replacement (at a dose of <=10 mg daily of prednisolone [or steroid equivalent]) and use of topical or inhaled corticosteroids are allowed. Intermittent use of steroids as pre-medication is also allowed.
12. Have clinical signs or symptoms of partial or complete gastrointestinal obstruction or active fistula, are at high risk for fistulization as per the Investigator s assessment, or have a history of gastrointestinal bleeding within the past 6 months;
13. Are females who are pregnant or breastfeeding;
Note: A urine pregnancy test will be performed at Screening (only in women of childbearing potential).
14. Have diminished pulmonary function defined as Grade >=2 [per NCI CTCAE v5.0] dyspnea and/or peripheral oxygen saturation <92% on room air (measured by pulse oximetry);
15. Have clinically significant cardiac disease defined as follows:
-New York Heart Association Class III or IV congestive heart failure;
-Left ventricular ejection fraction <45%, measured by echocardiogram or multigated acquisition scan at Screening;
-Acute coronary syndrome (eg, angina or myocardial infarction), stroke, or peripheral vascular disease within the last 12 months before Screening; or
-Uncontrolled clinically significant arrhythmia.
16. Have an average corrected QTcF outside the normal range per institutional values;
17. Have another significant concurrent, uncontrolled medical condition including, but not limited to, cardiologic, pulmonary, renal, hepatic, hematological, gastrointestinal, endocrine, neurological, cerebral, or psychiatric disease;
18. Have symptomatic or uncontrolled brain metastases (including leptomeningeal involvement) requiring current treatment (4 weeks from last cranial irradiation or <4 weeks from last steroids);
Note: Patients with an abnormal clinical examination or history will require a head CT or MRI to rule out or confirm brain metastases.
19. Have a known or suspected allergy to AVB-001 or known or suspected allergy to any components of AVB-001, including alginate or seaweed;
20. Have received at least 1 of the following approved cancer treatments prior to study drug administration:
-Immunomodulatory therapy within 7 days (excluding immune checkpoint inhibitors, as described below);
-Small molecule targeted therapy within 14 days or at least 5 half-lives, whichever is shorter;
-Endocrine therapy within 14 days (including tamoxifen, aromatase inhibitor, high-potency progesterone, and gonadotropin-releasing hormone analogue, etc);
-Radiotherapy within 14 days;
-Cytotoxic therapy within 21 days;
-Monoclonal antibody therapy within 21 days;
-Immunotherapy with an immune checkpoint inhibitor within 6 weeks;
-Other novel forms of interleukin (IL)-2 or IL-2-like molecules at any time point; or
-IP gene-targeted therapy at any time point.
21. Have any condition that, in the opinion of the Investigator, would lead to the inability of the patient to comply with the Protocol.
Principal Investigator
Referral Contact
For more information: