Batiraxcept for Recurrent Ovarian Carcinoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
M D Anderson Cancer Center, Houston, TX
Recurrent Ovarian Carcinoma+13 More
Batiraxcept - Drug
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of two immunotherapy drugs may help treat patients with ovarian, fallopian tube, or primary peritoneal cancer.

See full description

Eligible Conditions

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

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

This trial is evaluating whether Batiraxcept will improve 1 primary outcome in patients with Recurrent Ovarian Carcinoma. Measurement will happen over the course of Up to 1 year.

Up to 1 year
Incidence of adverse events

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Arm I (batiraxcept, durvalumab)
1 of 2
Arm II (durvalumab, batiraxcept)
1 of 2
Experimental Treatment

This trial requires 19 total participants across 2 different treatment groups

This trial involves 2 different treatments. Batiraxcept is the primary treatment being studied. Participants will be divided into 2 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Arm I (batiraxcept, durvalumab)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.
Arm II (durvalumab, batiraxcept)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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Durvalumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 1 year for reporting.

Closest Location

M D Anderson Cancer Center - Houston, TX

Eligibility Criteria

This trial is for female patients aged 18 and older. You must have received 1 prior treatment for Recurrent Ovarian Carcinoma or one of the other 13 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
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
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
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
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

Patient Q&A Section

Can platinum-resistant fallopian tube carcinoma be cured?

"Though relapse rates were significantly higher (p < 0.05) in the platinum-resistant cohort, both platinum-sensitive and platinum-resistant groups responded favorably to platinum-based chemotherapy. Patients who experience remission after platinum-based chemotherapy may benefit from repeat cycles of therapy if a similar remission rate can be obtained." - Anonymous Online Contributor

Unverified Answer

What are common treatments for platinum-resistant fallopian tube carcinoma?

"Most platinum-resistant fallopian tube carcinomas are treated with cisplatin-based chemotherapy, but platinum-resistant cancer still frequently metastasizes. Even with platinum-based chemotherapy, 20 to 30% of these patients also receive bevacizumab, an angiogenesis inhibitor, to combat platinum-resistant disease. This treatment has resulted in prolonged progression-free and overall survival, especially in patients with high-grade serous histology." - Anonymous Online Contributor

Unverified Answer

What is platinum-resistant fallopian tube carcinoma?

"The majority of patients (64 %) in the current study with platinum-resistant fallopian tube cancer did not have a complete response to their cancer-directed treatment. Survival was poor, with nearly all patients having died by 4.7 years after diagnosis in the current study." - Anonymous Online Contributor

Unverified Answer

What causes platinum-resistant fallopian tube carcinoma?

"The majority of these patients lacked a history of treatment with cisplatin. In contrast to our previous findings, the current study did not demonstrate an increased incidence of previous chemotherapy in advanced fallopian tube carcinoma. When previous chemotherapy was utilized, it is not associated with increased incidence of platinum-resistant tumours." - Anonymous Online Contributor

Unverified Answer

How many people get platinum-resistant fallopian tube carcinoma a year in the United States?

"Fallopian tube cancer is a rare disease and it is unclear why women have such a low risk of getting it the first time. Many of people in the United States get platinum-resistant fallopian tube cancer each year in the absence of exposure to platinum-based chemotherapy and because of our low rate of smoking and alcohol consumption, many people with fallopian tube cancer may be at low risk for platinum resistance. Because of this fact, we cannot predict the extent to which platinum resistance in fallopian tube cancer may develop or how many cases of platinum-resistant fallopian tube cancer will be detected in the United States in the near future." - Anonymous Online Contributor

Unverified Answer

What are the signs of platinum-resistant fallopian tube carcinoma?

"Signs of platinum-resistant fallopian tube carcinoma may not necessarily be easy to detect. However, when the tumor is in the right position, there is a high possibility of metastatic spillage into the peritoneal cavity, leading to ascites, pleural effusion, or both. Metastatic spillage is especially common in the early course, whereas lymph node metastases are more common in the advanced stage. This may explain the rarity of ascites or pleural effusion caused by primary tumor spillage into the peritoneal cavity." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for platinum-resistant fallopian tube carcinoma?

"Patients with platinum-resistant fallopian tube carcinoma have a very poor prognosis in terms of disease-free and overall survival rates. This fact is especially true for patients who have already had one surgical removal of the tubes. Survival rates for patients who have had one surgical removal of the fallopian tubes after platinum-resistant fallopian tube carcinoma appear to be more favorable when compared with those of patients who have a second-line surgical removal of the fallopian tubes. Patients treated with chemotherapy prior to platinum-resistant fallopian tube carcinoma also have improved survival rates and longer disease-free survival times when compared with patients treated with chemotherapy without prior surgical removal of the fallopian tubes. Prospective studies are needed to confirm these data." - Anonymous Online Contributor

Unverified Answer

How serious can platinum-resistant fallopian tube carcinoma be?

"Even without previous chemotherapy or platinum-containing cytotoxicity, PDX was the most promising indicator of poor prognosis in POF-PTC. answer: The main prognostic factors were tumor size and tumor stage. Since the pathogenesis of POF-PTC is poorly understood, further studies are needed, but FDG-PET may have a role in their management." - Anonymous Online Contributor

Unverified Answer

What does durvalumab usually treat?

"The median progression-free interval (PFI) has expanded for advanced, platinum-resistance borderline ovarian cancer. Durvalumab was not shown to prolong PFI, but was associated with an improvement in progression-free survival (PFS) time. Durvalumab is a biologics that targets PD-1 receptors on B lymphocytes (including T and B cells. Tumors usually have a [low percentage of B and T lymphocytes] and [higher percentage of myeloid-derived suppressor cells (MDSCs)], which can inhibit T-Cell response to Tumor cells." - Anonymous Online Contributor

Unverified Answer

What is durvalumab?

"Durvalumab is a human monoclonal antibody with immunomodulatory activity that has been developed for use in mature patients with moderate to severe platinum-resistant ovarian cancer." - Anonymous Online Contributor

Unverified Answer

What is the latest research for platinum-resistant fallopian tube carcinoma?

"The platinum resistance is a hallmark of advanced stage cancer, with poor prognosis. The most efficient chemotherapy to be utilized for platinum-resistant FTLTC cancer is likely to depend on the type of chemotherapy, dosage, drug-resistance phenotype and time point for drug administration. The platinum-resistant FTLTC cancer may benefit from an alternative or adjuvant treatment rather than platinum-based chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of platinum-resistant fallopian tube carcinoma?

"[About half of the women suffer platinum-induced ovarian toxicity, and platinum-resistant carcinoma develops about five years after platinum treatment. It is recommended that all women who have had an abortion or have had ovarian preservation for an ovarian germ-cell tumor should have another evaluation (i.e., a pelvic examination and computed tomography) at a minimum of five years after pelvic radiation to check for ovarian failure, metastases, and recurrent disease. If pelvic radiation was used, an option exists to consider an ovarian-sparing operation (i.e., removing only the remaining ovary and fallopian tube, but not the ovaries or uterus in the past)." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Recurrent Ovarian Carcinoma by sharing your contact details with the study coordinator.