BridgeMD
New treatment option for Cervical Cancer
Official title Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer
ClinicalTrials.gov ID: NCT06942416
What this study is testing
What is Paclitaxel and Cisplatin/ Carboplatin?
Paclitaxel and Cisplatin/ Carboplatin is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cervical cancer.
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
- The goal of this clinical trial is to evaluation the efficacy and safety of iparomlimab and tuvonralimab, paclitaxel + cisplatin/carboplatin combined with radiotherapy of locally recurrent and oligometastatic cervical cancer.The main questions it aims to answer are: 1. Does the combination therapy improve the overall response rate (ORR), progression-free survival (PFS), disease control rate (DCR), overall survival (OS), and safety in participants?
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Signed written informed consent prior to any trial-related procedures;
- Female, aged ≥18 and ≤75 years;
- ECOG PS 0-1;
- Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial...
- Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph...
See the full eligibility criteria
- Signed written informed consent prior to any trial-related procedures;
- Female, aged ≥18 and ≤75 years;
- ECOG PS 0-1;
- Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria;
- Locally recurrent or oligometastatic cervical cancer after initial treatment. Total recurrent + metastatic lesions ≤5.Oligometastasis criteria:Lymph node metastases within the same region = 1 lesion;Liver metastases ≤1...
- At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1;
- Available tumor tissue sample for biomarker assessment;
- Expected survival ≥6 months;
- Normal organ function (within 7 days pre-enrollment): (1) Hematological criteria (no transfusion/granulocyte/platelet-stimulating drugs within 14 days):
- Hemoglobin (Hb) ≥80 g/L
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L
- Platelets (PLT) ≥50×10⁹/L (2) No functional organic disease: a) ALT/AST ≤2.5×ULN, total bilirubin ≤1.5×ULN, ALP ≤3×ULN, albumin ≥30 g/L b) Serum Cr ≤1.5×ULN (if \>1.5×ULN, CrCl ≥50 mL/min by Cockcroft-Gault formula) c)...
- Alopecia/pigmentation (any grade)
- Peripheral neuropathy (≤Grade 2)
- Other toxicities where benefit-risk favors treatment 11. Non-sterilized/childbearing-potential females must:
- Use medical contraception (IUD/oral contraceptives/condoms) during treatment + 3 months post-treatment
- Negative serum/urine HCG within 7 days pre-enrollment
- Non-lactating 12. Expected compliance with protocol follow-up following criteria:
- Prior immunotherapy (e.g., immune checkpoint inhibitors);
- Pathological diagnosis of gastric-type adenocarcinoma;
- Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis...
- Current use of immunosuppressants or systemic/absorbable topical corticosteroids (equivalent to \>10 mg/day prednisone) for immunosuppression, continued within 2 weeks before enrollment;
- History of Grade 3-4 immune-related adverse events (irAEs) associated with prior anti-tumor immunotherapy;
- Poorly controlled cardiac conditions:
- NYHA Class II or higher heart failure
- Unstable angina
- Myocardial infarction within 6 months
- Clinically significant supraventricular/ventricular arrhythmia requiring treatment
- QTc \>450 ms (males) or \>470 ms (females); 7. Coagulation abnormalities (INR \>1.5 or PT \>16 s), bleeding tendency, or current thrombolytic/anticoagulant therapy; 8. Prior radiotherapy/chemotherapy/hormonal...
- HBV DNA \> upper limit of normal (ULN)
- HCV RNA \> ULN; 15. Use of other investigational drugs within 4 weeks before first dose; radiotherapy/local therapy within 2 weeks without full recovery; 16. Concurrent/prior malignancies (except cured basal cell...
- Severe comorbidities (including psychiatric disorders) requiring treatment
- Critical lab abnormalities
- Social/family factors compromising safety or data/sample collection.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong Recruiting, China
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 to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong Recruiting, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
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.