Is NCT05538091 recruiting in Pittsburgh, PA?

Yes, NCT05538091 is currently recruiting participants at its Pittsburgh, PA location. This platinum-resistant fallopian tube carcinoma clinical trial is actively enrolling qualified participants.

Is participation in this Pittsburgh clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Platinum-Resistant Fallopian Tube Carcinoma Clinical Trial in Pittsburgh, PA

Q: How do I join the platinum-resistant fallopian tube carcinoma clinical trial in Pittsburgh?

To join this clinical trial in Pittsburgh, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

About This Platinum-Resistant Fallopian Tube Carcinoma Study in Pittsburgh

This trial will treat patients with platinum resistant ovarian, fallopian tube or primary peritoneal cancer as defined by a progression free interval within six months of completion of most recent platinum-based treatment with a combination of vismodegib and atezolizumab. Despite recent improvements in treatment of ovarian cancer with the introduction of PARP inhibitors, response rates to therapy in the platinum resistant setting remain dismal with response rates of only 10-20% reported for single agent cytotoxic therapies. Given the poor prognosis and limited treatment options for these patients, this population is considered appropriate for trials of novel therapeutic candidates.

Sponsor: Ronald Buckanovich

Who Can Participate

Inclusion Criteria

Signed Informed Consent Form

Ability to comply with the study protocol, in the investigator's judgment

Histologically or cytologically confirmed epithelial ovarian, fallopian tube or primary peritoneal cancer

Platinum status, defined by disease progression during or following treatment with platinum-based chemotherapy within 6 months of completing therapy

Measurable or non-measurable but evaluable disease per RECIST v1.1 {Previously irradiated lesions can be considered as measurable disease only if progressive disease has been unequivocally documented at that site since radiation.}

Availability of a representative tumor specimen for exploratory biomarker research will be required for 12 patients (see Section 5.4.5 for information on tumor specimens)

ECOG Performance Status of 0-1

Life expectancy ≥ 3 months

Adequate hematologic and end-organ function, defined by the following laboratory test results, obtained within 14 days prior to initiation of study treatment: ANC ≥ 1.5 ⋅ 109/L (1500/μL) without granulocyte colony-stimulating factor support; Lymphocyte count ≥ 0.5 ⋅ 109/L (500/μL); Platelet count ≥ 100 ⋅ 109/L (100,000/μL) without transfusion; Hemoglobin ≥ 80 g/L (8 g/dL) (Patients may be transfused to meet this criterion.)

AST, ALT, and alkaline phosphatase (ALP) ≤ 2.5 ⋅ upper limit of normal (ULN), with the following exceptions:

Patients with documented liver metastases: AST and ALT ≤ 5 ⋅ ULN

Patients with documented liver or bone metastases: ALP ≤ 5 ⋅ ULN

Serum bilirubin ≤ 1.5 ⋅ ULN with the following exception:

Patients with known Gilbert disease: serum bilirubin ≤ 3 ⋅ ULN

Serum creatinine ≤ 1.5 ⋅ ULN

Serum albumin ≥ 25 g/L (2.5 g/dL)

For patients not receiving therapeutic anticoagulation: INR or aPTT ≤ 1.5 ⋅ ULN

For patients receiving therapeutic anticoagulation: stable anticoagulant regimen

Negative HIV test at screening, with the following exception: patients with a positive HIV test at screening are eligible if they are stable on anti-retroviral therapy, have a CD4 count \> 200, and have an undetectable viral load.

Negative hepatitis B surface antigen (HBsAg) test at screening

For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods as defined below:

Women must remain abstinent or use contraceptive methods with a failure rate of \< 1% per year during the treatment period and for 5 months after the final dose of atezolizumab and for 24 months after the final dose of vismodegib. Women must refrain from donating eggs during this same period.

A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (≥ 12 continuous months of amenorrhea with no identified cause other than menopause), and has not undergone surgical sterilization (removal of ovaries and/or uterus). The definition of childbearing potential may be adapted for alignment with local guidelines or requirements.

Examples of contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception.

Exclusion Criteria

Inability or unwillingness to swallow capsules

Inability or unwillingness to comply with study procedures

History of leptomeningeal disease

Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently) o Patients with indwelling catheters (e.g., PleurX→) are allowed.

Uncontrolled or symptomatic hypercalcemia (ionized calcium \> 1.5 mmol/L, calcium \> 12 mg/dL or corrected serum calcium \> ULN)

Active or history of autoimmune disease or immune deficiency, including, but not limited to, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener granulomatosis, Sjögren syndrome, Guillain-Barré syndrome, or multiple sclerosis (see Appendix 9) for a more comprehensive list of autoimmune diseases and immune deficiencies), with the following exceptions:

Patients with a history of autoimmune-related hypothyroidism who are on thyroid-replacement hormone are eligible for the study.

Patients with controlled Type 1 diabetes mellitus who are on an insulin regimen are eligible for the study.

Patients with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis are excluded) are eligible for the study provided all of following conditions are met:

Rash must cover \< 10% of body surface area

Disease is well controlled at baseline and requires only low-potency topical corticosteroids

No occurrence of acute exacerbations of the underlying condition requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or high-potency or oral corticosteroids within the previous 12 months

History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography (CT) scan (History of radiation pneumonitis in the radiation field (fibrosis) is permitted).

Active tuberculosis

Significant cardiovascular disease (such as New York Heart Association Class II or greater cardiac disease, myocardial infarction, or cerebrovascular accident) within 3 months prior to initiation of study treatment, unstable arrhythmia, or unstable angina

Major surgical procedure, other than for diagnosis, within 4 weeks prior to initiation of study treatment, or anticipation of need for a major surgical procedure during the study

History of malignancy other than ovarian cancer within 5 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate \> 90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal carcinoma in situ, or Stage I uterine cancer

Severe infection within 4 weeks prior to initiation of study treatment, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia

Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment

Patients receiving prophylactic antibiotics (e.g., to prevent a urinary tract infection or chronic obstructive pulmonary disease exacerbation) are eligible for the study.

Prior allogeneic stem cell or solid organ transplantation

Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding that contraindicates the use of an investigational drug, may affect the interpretation of the results, or may render the patient at high risk from treatment complications

Treatment with a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during atezolizumab treatment or within 5 months after the final dose of atezolizumab

Current treatment with anti-viral therapy for HBV

Treatment with investigational therapy within 28 days prior to initiation of study treatment

Treatment with systemic immunostimulatory agents (including, but not limited to, interferon and interleukin 2 \[IL-2\]) within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to initiation of study treatment

Treatment with systemic immunosuppressive medication (including, but not limited to, corticosteroids, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-TNF-α agents) within 2 weeks prior to initiation of study treatment, or anticipation of need for systemic immunosuppressive medication during study treatment, with the following exceptions:

Patients who received acute, low-dose systemic immunosuppressant medication or a one-time pulse dose of systemic immunosuppressant medication (e.g., 48 hours of corticosteroids for a contrast allergy) are eligible for the study after Principal Investigator confirmation has been obtained.

Patients who received mineralocorticoids (e.g., fludrocortisone), corticosteroids for chronic obstructive pulmonary disease (COPD) or asthma, or low-dose corticosteroids for orthostatic hypotension or adrenal insufficiency are eligible for the study.

History of severe allergic anaphylactic reactions to chimeric or humanized antibodies or fusion proteins

Known hypersensitivity to Chinese hamster ovary cell products or to any component of the atezolizumab formulation

Known allergy or hypersensitivity to any component of the vismodegib formulation

Agreement not to donate blood or blood products during the study and for 24 months after discontinuation of vismodegib.

Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab and for 24 months after the final dose of vismodegib.

Women of childbearing potential must have a negative serum pregnancy test result within 14 days prior to initiation of study treatment.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Pittsburgh?

Yes, this clinical trial (NCT05538091) has an active research site in Pittsburgh, PA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Platinum-Resistant Fallopian Tube Carcinoma Treatment Options in Pittsburgh, PA

If you're searching for platinum-resistant fallopian tube carcinoma treatment options in Pittsburgh, PA, this clinical trial (NCT05538091) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Pittsburgh research site is actively enrolling participants for this clinical trial. You'll receive care from experienced platinum-resistant fallopian tube carcinoma specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all platinum-resistant fallopian tube carcinoma clinical trials near you to find additional studies recruiting in your area.

Platinum-Resistant Fallopian Tube Carcinoma Clinical Trial in Pittsburgh, PA

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