Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer

Phase II, Single-Arm, Multicenter Clinical Study of Iparomlimab and Tuvonralimab in Combination With Paclitaxel Plus Cisplatin/Carboplatin and Radiotherapy for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer

Iparomlimab and Tuvonralimab With Chemoradiation for the Treatment of Locally Recurrent and Oligometastatic Cervical Cancer (NCT06942416) is a Phase 2 interventional studying Cervical Cancer and Neoplasm Recurrence, Local, sponsored by Shandong Cancer Hospital and Institute. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

About This Trial

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? 2. What are the predictive biomarkers of treatment efficacy, and how can this information better guide the use of immune-oncology drugs in combination therapy? Participants will: * Receive iparomlimab and tuvonralimab, Paclitaxel + Cisplatin/Carboplatin and radiation therapy according to a specified protocol. * Visit the clinic for regular checkups and tests throughout the treatment period. * Be monitored for and have records kept of ORR, PFS, DCR, OS, and safety. * Provide hematologic、tissue and stool samples to explore biomarkers. This study will help determine if this combination therapy can become a new standard of care for patients with locally recurrent and oligometastatic cervical cancer as well as identify biomarkers to better guide treatment strategies.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Cervical Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 36 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Signed written willing to sign a consent form prior to any trial-related procedures; 2. Female, aged ≥18 and ≤75 years; 3. ECOG PS 0-1; 4. diagnosed by tissue sample (biopsy-confirmed) primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria; 5. 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 lesion;Lung metastases ≤3 lesions 6. At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1; 7. Available tumor tissue sample for biomarker assessment; 8. Expected survival ≥6 months; 9. Normal organ function (within 7 days pre-enrollment): (1) Hematological criteria (no transfusion/granulocyte/platelet-stimulating drugs within 14 days): 1. Hemoglobin (Hb) ≥80 g/L 2. Absolute neutrophil count (ANC) ≥1.5×10⁹/L 3. 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) PT prolongation ≤6 sec, APTT ≤1.5×ULN d) TSH ≤ULN (if abnormal, FT3/FT4 must be normal) f) LVEF \>50% 10. Prior anti-tumor treatment toxicities recovered to ≤Grade 1 (CTCAE v5.0) pre-treatment, excluding: - 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: 1. Prior immunotherapy (e.g., immune checkpoint inhibitors); ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: 1. Signed written informed consent prior to any trial-related procedures; 2. Female, aged ≥18 and ≤75 years; 3. ECOG PS 0-1; 4. Histologically or cytologically confirmed primary cervical cancer (squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma) at initial diagnosis, meeting clinical diagnostic criteria; 5. 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 lesion;Lung metastases ≤3 lesions 6. At least one measurable lesion (including primary lesion) suitable for radiotherapy and evaluable per RECIST v1.1; 7. Available tumor tissue sample for biomarker assessment; 8. Expected survival ≥6 months; 9. Normal organ function (within 7 days pre-enrollment): (1) Hematological criteria (no transfusion/granulocyte/platelet-stimulating drugs within 14 days): 1. Hemoglobin (Hb) ≥80 g/L 2. Absolute neutrophil count (ANC) ≥1.5×10⁹/L 3. 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) PT prolongation ≤6 sec, APTT ≤1.5×ULN d) TSH ≤ULN (if abnormal, FT3/FT4 must be normal) f) LVEF \>50% 10. Prior anti-tumor treatment toxicities recovered to ≤Grade 1 (CTCAE v5.0) pre-treatment, excluding: * 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: 1. Prior immunotherapy (e.g., immune checkpoint inhibitors); 2. Pathological diagnosis of gastric-type adenocarcinoma; 3. Active autoimmune disease or history of autoimmune disease (including but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism). Exceptions: vitiligo; childhood asthma fully resolved without intervention in adulthood. Exclusion: asthma requiring bronchodilator therapy; 4. Current use of immunosuppressants or systemic/absorbable topical corticosteroids (equivalent to \>10 mg/day prednisone) for immunosuppression, continued within 2 weeks before enrollment; 5. History of Grade 3-4 immune-related adverse events (irAEs) associated with prior anti-tumor immunotherapy; 6. Poorly controlled cardiac conditions:  1. NYHA Class II or higher heart failure 2. Unstable angina 3. Myocardial infarction within 6 months 4. Clinically significant supraventricular/ventricular arrhythmia requiring treatment 5. 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 therapy/surgery/targeted therapy completed \<4 weeks before study treatment (or \<5 drug half-lives, whichever is longer); unresolved toxicities (excluding alopecia) from prior therapies \>CTCAE Grade 1; 9. Poorly controlled third-space effusion requiring drainage before first trial drug administration; 10. Significant hemoptysis (≥2.5 mL/day) within 2 months before randomization; 11. Known hereditary/acquired bleeding/thrombotic disorders (e.g., hemophilia, coagulation dysfunction, thrombocytopenia, hypersplenism); 12. Active infection or unexplained fever \>38.5°C during screening/before first dose; 13. Objective evidence of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-induced pneumonitis, or severe pulmonary dysfunction; 14. Immunodeficiency (e.g., HIV infection) or active hepatitis: * 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 carcinoma/cervical carcinoma in situ); 17. Planned concurrent systemic anti-tumor therapy during the study; 18. Live vaccination within 4 weeks before treatment or planned during the study; 19. Other conditions potentially requiring study termination per investigator judgment: * Severe comorbidities (including psychiatric disorders) requiring treatment * Critical lab abnormalities * Social/family factors compromising safety or data/sample collection.

Treatments Being Tested

DRUG

Paclitaxel and Cisplatin/ Carboplatin

Paclitaxel and Cisplatin Paclitaxel: 135 mg/m², intravenous infusion, Day 1, every 3 weeks (Q3W). Cisplatin: 75 mg/m², intravenous infusion, Days 1-3, every 3 weeks (Q3W). Carboplatin 0.3-0.4g/m², intravenous infusion, Day 1, Q3W .Duration: 4-6 cycles.

DRUG

Iparomlimab and Tuvonralimab

Iparomlimab and Tuvonralimab 5mg/kg, intravenous infusion, Day 1, Q3W. Duration: Continuous administration until disease progression, death, intolerable toxicity, subject's voluntary withdrawal, investigator's decision for withdrawal, or a maximum of 24 months.

RADIATION

Radiotherapy

Site Selection: Original site, lymph nodes, lung metastasis, bone metastasis, adrenal metastasis, brain metastasis, and other relatively isolated, well-vascularized lesions. Select at least one suitable lesion for radiotherapy based on the impact of the recurrent or metastatic lesion on the body, prioritizing lesions that cause symptoms, are life-threatening, or are expected to cause symptoms.All tumor lesions will be irradiated, which can be done in phases. Dosage and Fractionation: Conventional or hypofractionated radiotherapy, with a biologically effective dose (BED) of ≥ 72 Gy. Dose adjustments can be made for brain metastases. Timing: After completing relevant baseline examinations, radiotherapy can be implemented generally after 4-6 cycles of systemic therapy, or after the first cycle for small, solitary metastatic lesions. echnique: IMRT, TOMO, SBRT, 3D-BT, interstitial implantation therapy, or proton therapy.

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Shandong Cancer Hospital Affiliated to Shandong First Medical University

Jinan, Shandong Recruiting, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06942416), the sponsor (Shandong Cancer Hospital and Institute), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06942416 clinical trial studying?

Who can participate in NCT06942416?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06942416?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06942416. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06942416. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.