Etigilimab for Recurrent Fallopian Tube Clear Cell Adenocarcinoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
M D Anderson Cancer Center, Houston, TX
Recurrent Fallopian Tube Clear Cell Adenocarcinoma+9 More
Etigilimab - Biological
Eligibility
18+
Female
Eligible conditions
Select

Study Summary

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

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Eligible Conditions

  • Recurrent Fallopian Tube Clear Cell Adenocarcinoma
  • Recurrent Primary Peritoneal Clear Cell Adenocarcinoma
  • Recurrent Ovarian Clear Cell Adenocarcinoma
  • Recurrent Platinum-Resistant Ovarian Carcinoma
  • Recurrent Platinum-Resistant Primary Peritoneal Carcinoma
  • Recurrent Platinum-Resistant Fallopian Tube Carcinoma

Treatment Effectiveness

Study Objectives

This trial is evaluating whether Etigilimab will improve 2 primary outcomes and 4 secondary outcomes in patients with Recurrent Fallopian Tube Clear Cell Adenocarcinoma. Measurement will happen over the course of From the date of dual therapy treatment initiation to the date of initial radiologic evidence of progressive disease or death, assessed up to 90 days after completion of treatment.

Day 90
Median immune-related progression free survival (irPFS)
Up to 90 days
Disease control rate (DCR)
Incidence of adverse events
Objective response rate (ORR)
Year 1
Immunological changes
Molecular changes

Trial Safety

Safety Estimate

2 of 3
This is better than 68% of similar trials

Trial Design

1 Treatment Group

Treatment (etigilimab, nivolumab)
1 of 1
Experimental Treatment

This trial requires 20 total participants across 1 different treatment group

This trial involves a single treatment. Etigilimab is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Treatment (etigilimab, nivolumab)Patients receive etigilimab IV over 30-90 minutes on days 1 and 15 and nivolumab IV over 30 minutes on days 2 and 15 of cycle 1 and days 1 and 15 of subsequent cycles. Cycles repeat every 28 days for up to 24 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Nivolumab
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 1 year
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly through study completion, an average of 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 Fallopian Tube Clear Cell Adenocarcinoma or one of the other 9 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:
The person must be at least 18 years old when they start the study. show original
The subject is willing and able to comply with the protocol for the duration of the study, including undergoing treatment, biopsy, and scheduled visits and examinations including follow up. show original
The text is discussing a woman who has recurrent clear cell ovarian, peritoneal, or fallopian tube cancer show original
Hemoglobin levels must be at least 9.0 g/dL within the 28 days before starting the study medication. show original
A participant has to have a platelet count of 100,000 or more within 28 days of starting the study in order to be in the study. show original
Have measurable disease based on modified Response Evaluation Criteria in Solid Tumors (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. Pretreatment imaging must be performed within 4 weeks of starting therapy
(fully ambulatory and capable of all self-care activities) The Eastern Cooperative Oncology Group (ECOG) defines performance status as 0 or 1 for people who are fully ambulatory and capable of all self-care activities. show original
The ability to provide signed informed consent is the ability to understand the risks and benefits of a study and to provide written consent that is understood by the investigator. show original
Platinum resistant tumors are those that either progress on a platinum-containing treatment regimen or relapse within 180 days of a previous platinum treatment. show original
Participants who had an absolute neutrophil count (ANC) of more than 1,500/mm3 within 28 days of starting study treatment were included in the analysis. show original

Patient Q&A Section

What is the latest research for adenocarcinoma, clear cell?

"The prognosis is poor in patients treated with surgery alone because of their advanced-stage disease and poor performance status. Patients with ovarian metastasis have better prognoses after cytoreductive surgery and intraperitoneal chemotherapy than patients with no evidence of ovarian metastasis. A prospective randomized trial would be necessary to determine whether patients with ovarian metastases benefit from cytoreductive surgery followed by intraperitoneal chemotherapy." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of adenocarcinoma, clear cell?

"Adenocarcinoma, clear cell is a rare type of tumor. Therefore, its causes are not well known. The most commonly reported cause is chronic renal failure. For example, pimozide usage is associated with increased risk of adenocarcinoma, clear cell in renal transplant recipients. We have also demonstrated that adenocarcinoma, clear cell has low expression of p16(INK4a) gene. Thus, we believe that this tumor is caused by other factors besides p53 mutation. Also, our results suggest that p53 mutation does not play a major role in the pathogenesis of this neoplasm." - Anonymous Online Contributor

Unverified Answer

Is etigilimab safe for people?

"Etigilimab was well tolerated both In a recent study and in phase III trials. Serious adverse events were uncommon (3%). The most common side effects were infusion reactions (mostly injection site reactions), fatigue, nausea, vomiting, and diarrhoea. Results from a recent paper support the continued development of etigilimab in combination regimens for advanced solid tumours." - Anonymous Online Contributor

Unverified Answer

What is etigilimab?

"Etigilimab is an anti-PDGFR antibody used in a number of advanced solid tumors in conjunction with other therapies. It has shown some efficacy in proof of concept studies in metastatic renal cell carcinoma (mRCC) and non-small cell lung cancer (NSCLC). While etigilimab has been granted orphan drug status in both those indications it has not yet progressed to phase III clinical trials. The first published clinical trial was terminated early due to safety concerns. A second clinical trial has recently been initiated in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). This trial is being conducted in collaboration with AstraZeneca." - Anonymous Online Contributor

Unverified Answer

Who should consider clinical trials for adenocarcinoma, clear cell?

"The majority of patients enrolled in this trial were not eligible for participation in conventional trials. In the absence of any evidence on the efficacy of enrollment criteria for metastatic sarcomas, prospective clinical trials evaluating eligibility criteria for metastatic sarcomas are warranted." - Anonymous Online Contributor

Unverified Answer

What are the latest developments in etigilimab for therapeutic use?

"Etiglitazar is a fully human monoclonal antibody directed against Interleukin-6 receptor alpha chain. It is a potent inhibitor of IL-6 signals and exerts its effects by blocking the interaction between IL-6 and IL-6Ralpha subunit. Etiglitazar inhibits the internalization of IL-6Ralpha by inhibiting the formation of endosomes, thus preventing IL-6 from binding to its specific receptor and thereby reducing the downstream signalling pathways." - Anonymous Online Contributor

Unverified Answer

What are common treatments for adenocarcinoma, clear cell?

"Treatment strategies for clear cell carcinoma are not well defined. In a recent study, we summarize the current knowledge on the management of clear cell carcinoma and propose an algorithm for treatment based on our experience and the literature." - Anonymous Online Contributor

Unverified Answer

What is adenocarcinoma, clear cell?

"Adenocarcinoma, clear cell has 3 main subtypes based on the appearance of its cells under the microscope: clear cells, hobnail cells, and papillary cells. The clear cell form dominates among the three. In our study, the majority of patients had either clear cell or hobnail cell histology (97% vs 3%, respectively). In contrast, only 1 patient out of 5 had papillary cell histology. This may be due to the rarity of papillary cell tumors." - Anonymous Online Contributor

Unverified Answer

What is the average age someone gets adenocarcinoma, clear cell?

"This is an important question because adenocarcinomas of the pancreas can occur at any age, but most commonly occurs among middle-aged individuals. The incidence increases steadily in the fourth decade of life." - Anonymous Online Contributor

Unverified Answer

Has etigilimab proven to be more effective than a placebo?

"Etigilimab administered once weekly was significantly more effective than a placebo in this phase II study. Efficacy of etigilimab was demonstrated in all subgroups except the elderly. Data from a recent study obtained suggest that further evaluations using etigilimab may be necessary." - 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.
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