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Compares treatment options for Locally Advanced Cervical Adenocarcinoma
Official title Induction Pembrolizumab and Chemotherapy Followed by Pembrolizumab Before Chemoradiation and Pembrolizumab Maintenance Compared to Standard Chemoradiation With Pembrolizumab Followed by Pembrolizumab Maintenance in High-Risk Cervical Cancer
ClinicalTrials.gov ID: NCT07061977
What this study is testing
What is Carboplatin?
Carboplatin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for locally advanced cervical adenocarcinoma.
Also referred to as Blastocarb, Carboplat.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This phase III trial compares the addition of induction chemotherapy, with carboplatin, paclitaxel and pembrolizumab, to chemotherapy and radiation, with cisplatin and pembrolizumab followed by pembrolizumab maintenance for the treatment of patients with cervical cancer that has spread to nearby tissue or lymph nodes (locally advanced). Carboplatin is in a class of medications known as platinum-containing compounds.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma...
- Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:
- IIIA (T3aN0M0)
- IIIB (T3bN0M0)
- IIIC1(T3aN1M0, T3bN1M0)
See the full eligibility criteria
- Patients must have pathologically confirmed newly diagnosed cervical cancer. Eligible pathologic types: squamous cell carcinoma, adenocarcinoma, adenosquamous cell carcinoma
- Patients must have locally advanced cervical cancer (LACC) with T3 or T4 disease with or without lymph node involvement:
- IIIA (T3aN0M0)
- IIIB (T3bN0M0)
- IIIC1(T3aN1M0, T3bN1M0)
- IIIC2 (T3aN2M0, T3bN2M0)
- IVA (T4aN0M0, T4aN1M0, T4aN2M0) No prior hysterectomy defined as removal of the entire uterus.
- NOTE: prior partial/subtotal hysterectomy for reasons other than cervical cancer are eligible to participate in the study. No plan to perform a hysterectomy as part of initial cervical cancer therapy. No paraaortic...
- Note: Nodal status can be confirmed by imaging (CT, MRI, or PET/CT), fine needle aspirate/core biopsy, extra peritoneal biopsy, laparoscopic biopsy, or lymphadenectomy. Radiologic definition of lymph node staging:
- One or more pelvic lymph nodes with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
- One or more pelvic lymph nodes with short axis diameter of ≥ 10 mm and standardized uptake value maximum (SUVmax) ≥ 2.5 by fludeoxyglucose (FDG)-PET
- One or more para-aortic lymph node with short axis diameter of ≥ 15 mm (axial plane) by CT or MRI, and/or
- One or more para-aortic lymph node with short axis diameter of ≥ 10 mm and SUVmax ≥ 2.5 by FDG-PET
- No prior definitive surgical, radiation, or systemic therapy for cervical cancer
- No prior immunotherapy
- No prior pelvic radiation therapy for any disease
- Age ≥ 18
- Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
- Not pregnant and not nursing
- Absolute neutrophil count (ANC) ≥ 1,500 cells/mm\^3
- Platelets ≥ 100,000 cells/mm\^3
- Hemoglobin ≥ 8 g/dl (Note: The use of transfusion or other intervention to achieve hemoglobulin [Hgb] ≥ 8 g/dl is acceptable)
- Creatinine clearance (CrCL) of ≥ 50 mL/min by the Cockcroft-Gault formula
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x institutional ULN may be enrolled)
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x institutional ULN
- Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association...
- No active infection requiring parenteral antibiotics
- No live vaccine within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacille...
- No diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior registration
- No active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin...
- No history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
- No history of allergic reaction to the study agent(s) or compounds of similar chemical or biologic composition to the study agent(s) (or any of its excipients)
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Fayetteville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Bellflower, California, United States
- Corona, California, United States
- Duarte, California, United States
- Harbor City, California, United States
- Irvine, California, United States
- La Jolla, California, United States
- Lancaster, California, United States
- Los Angeles, California, United States
- Orange, California, United States
- Panorama City, California, United States
- San Diego, California, United States
- San Marcos, California, United States
- South Pasadena, California, United States
- Upland, California, United States
- Woodland Hills, California, United States
+ 213 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Fayetteville, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Springdale, Arkansas, United States; Bellflower, California, United States and 227 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.