AVB-S6-500 and Durvalumab in Treating Patients With Platinum-Resistant or Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

NCT04019288 | Terminated Phase 1 Results FDA Drug

• 2 other identifiers: 2019-0149NCI-2019-02580
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This trial studies the side effects and best dose of AVB-S6-500 when given together with durvalumab in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that is resistant to platinum therapy or has come back. Immunotherapy with AVB-S6-500 and durvalumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Conditions

Platinum-Resistant Fallopian Tube Carcinoma; Platinum-Resistant Ovarian Carcinoma; Platinum-Resistant Primary Peritoneal Carcinoma; Recurrent Fallopian Tube Carcinoma; Recurrent Ovarian Carcinoma; Recurrent Primary Peritoneal Carcinoma; Refractory Fallopian Tube Carcinoma; Refractory Ovarian Carcinoma; Refractory Primary Peritoneal Carcinoma

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Adverse Events

  35 months

Secondary Outcomes (3)

• To Estimate Objective Response Rate to Combination AVB-S6-500 and Durvalumab Therapy

  35 months

• To Estimate the Median Immune-related Progression Free Survival (irPFS) as Well as Overall Survival OS by RECIST 1.1 After Treatment With Combination Durvalumab and AVB-S6-500

  35 months

• To Investigate Molecular and Immunological Changes Associated With the Combination of AVBS6-500 and Durvalumab.

  35 months

Study Arms (2)

Arm I (batiraxcept, durvalumab)

EXPERIMENTAL

Patients receive batiraxcept IV over 60 minutes on days 1, 15, and 29 of cycle 0, and on days 1 and 15 of subsequent cycles. Beginning cycle 1, patients also receive durvalumab IV over 60 minutes on day 1. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Batiraxcept; Biological: Durvalumab

Arm II (durvalumab, batiraxcept)

EXPERIMENTAL

Patients receive durvalumab IV over 60 minutes on days 1 and 22 of cycle 0 and on day 1 of subsequent cycles. Beginning cycle 1, patients also receive batiraxcept IV over 60 minutes on days 1 and 15. Cycle 0 continues for 6 weeks and subsequent cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.

Drug: Batiraxcept; Biological: Durvalumab

Interventions

Batiraxcept DRUG

Given IV

Also known as: Anti-AXL Fusion Protein AVB-S6-500, AVB S6 500, AVB-500, AVB-S6-500, AVBS6500, AXL Fc Fusion Protein AVB-S6-500, RUGA-S6

Arm I (batiraxcept, durvalumab); Arm II (durvalumab, batiraxcept)

Durvalumab BIOLOGICAL

Given IV

Also known as: Imfinzi, Immunoglobulin G1, Anti-(Human Protein B7-H1) (Human Monoclonal MEDI4736 Heavy Chain), Disulfide with Human Monoclonal MEDI4736 Kappa-chain, Dimer, MEDI-4736, MEDI4736

Arm I (batiraxcept, durvalumab); Arm II (durvalumab, batiraxcept)

Eligibility Criteria

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

You may qualify if:

• Ability to provide signed informed consent
• Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up
• Histology (reviewed at MD Anderson Cancer Center \[MDACC\]) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer
• Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment
• Have measurable disease based on modified RECIST 1.1. For the purposes of this study measurable disease is defined at least one "target lesion" that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be \> 20 mm when measured by conventional techniques, including palpation, plain x-ray, computed tomography (CT), and magnetic resonance imaging (MRI), or \> 10 mm when measured by spiral CT. The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies. Pre-treatment imaging must be performed within 4 weeks of starting therapy
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of \>= 12 weeks
• Body weight \> 30 kg. Note: if subject's weight falls below 30 kg during study but the patient is otherwise eligible to continue investigational therapy the dose of durvalumab will be modified to be weight-based (20 mg/kg for the 1500 mg dose; modification is not required for 1120 mg dose)
• Hemoglobin \>= 9.0 g/dL
• Absolute neutrophil count (ANC) \> 1500/mm\^3
• Platelet count \>= 100 x 10\^9/L (\> 75,000/mm\^3)
• Serum bilirubin =\< 1.5 x upper limit of normal (ULN)
• This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician
• Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase \[SGPT\]) =\< 2.5 x ULN unless liver metastases are present, in which case it must be =\< 5 x ULN
• Measured creatinine clearance (CL) \> 40 mL/min or calculated creatinine CL \> 40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance

You may not qualify if:

• Participation in another clinical study with an investigational product (IP) during the last 28 days
• Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
• Receipt of the last dose of anticancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies) =\< 28 days prior to the first dose of study drug. If sufficient wash-out time has not occurred due to the schedule or pharmacokinetic (PK) properties of an agent, a longer wash-out period will be required, as agreed by AstraZeneca, Aravive, and the investigator
• Patients with grade \>= 2 neuropathy will be evaluated on a case-by-case basis after consultation with the primary investigator
• Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the study physician
• Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment
• Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of IP. Note: Local surgery of isolated lesions for palliative intent is acceptable
• History of allogenic organ transplantation
• Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease \[e.g., colitis or Crohn's disease\], diverticulitis \[with the exception of diverticulosis\], systemic lupus erythematosus, sarcoidosis syndrome, or Wegener syndrome \[granulomatosis with polyangiitis, Graves' disease, rheumatoid arthritis, hypophysitis, uveitis, etc\]). The following are exceptions to this criterion:
• Patients with vitiligo or alopecia;
• Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement;
• Any chronic skin condition that does not require systemic therapy;
• Patients without active disease in the last 5 years may be included but only after consultation with the primary investigator;
• Patients with celiac disease controlled by diet alone
• Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring Adverse Events (AEs) or compromise the ability of the patient to give written informed consent

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Aravive Biologics Inc: collaborator
• AstraZeneca: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center

MeSH Terms

Conditions

Fallopian Tube Neoplasms; Ovarian Neoplasms

Interventions

AVB-500 fusion protein; durvalumab; Immunoglobulin G; Disulfides

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

Intervention Hierarchy (Ancestors)

Immunoglobulin Isotypes; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Sulfides; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrogen Sulfide; Sulfur Compounds; Organic Chemicals

Results Point of Contact

• Title: Amir A Jazaeri
• Organization: M.D. Anderson Cancer Center

aajazaeri@mdanderson.org

713-745-1613

Study Officials

• Amir A Jazaeri

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2019
• First Posted: July 15, 2019
• Study Start: December 3, 2019
• Primary Completion: October 24, 2024
• Study Completion: October 24, 2024
• Last Updated: June 11, 2025
• Results First Posted: June 11, 2025

Record last verified: 2025-05

Locations

US (1)