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New treatment option for Recurrent or Metastatic Nasopharyngeal Carcinoma
Official title Combination Therapy for PD-1 Resistant Recurrent or Metastatic Nasopharyngeal Carcinoma: A Bayesian Adaptive Phase II Trial
ClinicalTrials.gov ID: NCT07070479
What this study is testing
What is Ivonescimab?
Ivonescimab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for recurrent or metastatic nasopharyngeal carcinoma.
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 is a prospective, Bayesian adaptive, phase II clinical trial designed to evaluate the safety and efficacy of four treatment regimens in patients with recurrent (unamenable to local therapy) or metastatic nasopharyngeal carcinoma (NPC) who have failed after at least one prior platinum-containing standard regimen and anti-PD-1/PD-L1 therapy. The four treatment arms include: 1.
- Phase 2: a mid-size study of how well it works
- 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 to 70
You may be able to join if
- Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or...
- Age between 18 and 70 years.
- Performance Status (PS) score of 0 or 1.
- Disease progression after prior platinum-based doublet chemotherapy.
- Received at least one line of systemic therapy previously. (Progression occurring during or within 6 months after definitive concurrent...
You likely can't join if
- Locoregional recurrent lesions that are amenable to definitive (curative) treatment, such as surgery.
- Prior treatment with any regimen included in the study protocol.
- Prior use of agents targeting the VEGF or VEGFR pathway.
- Diagnosis and/or treatment of another malignancy within the past 5 years, with the exception of adequately treated carcinoma in situ of the cervix...
- Receipt of surgery, chemotherapy, radiotherapy, immunotherapy, any investigational agent, or other anti-cancer therapy within 4 weeks prior to...
- Tumor encasement of the internal carotid artery or evidence of nasopharyngeal necrosis observed on endoscopy prior to enrollment.
See the full eligibility criteria
Who can join
- Histologically and/or cytologically confirmed recurrent or metastatic non-keratinizing nasopharyngeal carcinoma (either differentiated or undifferentiated subtype, corresponding to WHO type II or III).
- Age between 18 and 70 years.
- Performance Status (PS) score of 0 or 1.
- Disease progression after prior platinum-based doublet chemotherapy.
- Received at least one line of systemic therapy previously. (Progression occurring during or within 6 months after definitive concurrent chemoradiotherapy, neoadjuvant/adjuvant therapy, or treatment completion may be...
- Resistance to anti-PD-1 antibody therapy (either combination or sequential), including primary or secondary resistance（PD-1 exposure must be at least 6 weeks.）
- At least one measurable lesion according to RECIST 1.1 criteria.
- All acute toxicities from prior anti-tumor therapies have resolved to grade ≤1 (per NCI-CTCAE v5.0) or meet the specified inclusion/exclusion thresholds. (Certain toxicities such as alopecia, hair color changes, nail...
- Adequate organ function: Hematology: WBC ≥ 4000/μL, absolute neutrophil count ≥ 2000/μL, hemoglobin ≥ 9 g/dL, platelets ≥ 100,000/μL. Liver function: Total bilirubin ≤ 1.5 × upper limit of normal (ULN) (patients with...
- Estimated life expectancy of at least 3 months.
- Signed informed consent and willingness and ability to comply with study visits, treatment plans, laboratory tests, and other study procedures.
What rules you out
- Locoregional recurrent lesions that are amenable to definitive (curative) treatment, such as surgery.
- Prior treatment with any regimen included in the study protocol.
- Prior use of agents targeting the VEGF or VEGFR pathway.
- Diagnosis and/or treatment of another malignancy within the past 5 years, with the exception of adequately treated carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, localized prostate cancer, or...
- Receipt of surgery, chemotherapy, radiotherapy, immunotherapy, any investigational agent, or other anti-cancer therapy within 4 weeks prior to enrollment (or within 2 weeks for palliative radiotherapy).
- Tumor encasement of the internal carotid artery or evidence of nasopharyngeal necrosis observed on endoscopy prior to enrollment.
- Any significant bleeding event (≥ Grade 2, CTCAE v5.0) within 4 weeks prior to enrollment, or visible hemoptysis defined as ≥ 1/2 teaspoon of fresh red blood or blood clots with little or no sputum. Recurrent positive...
- Active peptic ulcers or gastrointestinal surgery within 1 month prior to enrollment; history within 6 months of abdominal fistula, gastrointestinal perforation, intra-abdominal abscess, gastrointestinal hemorrhage...
- Uncontrolled hypertension (systolic \>140 mmHg or diastolic \>90 mmHg) despite antihypertensive therapy; coronary artery disease ≥ Grade II; or any of the following within 6 months prior to enrollment: myocardial...
- History of bleeding diathesis, hemorrhagic disorders, or coagulopathy; current use of anticoagulants or antiplatelet agents including warfarin, heparin, aspirin \>325 mg/day, ticlopidine, clopidogrel, or cilostazol...
- Severe infection requiring intravenous antibiotics, antifungals, or antivirals within 4 weeks prior to the first dose, or unexplained fever \>38.5°C within 7 days prior to the first dose; baseline WBC \>15 × 10⁹/L.
- Known hypersensitivity to study drugs or excipients, or a history of severe hypersensitivity reactions such as generalized rash/erythema, hypotension, bronchospasm, angioedema, or anaphylaxis.
- Conditions that may affect oral drug absorption, including dysphagia, nausea/vomiting, chronic diarrhea, or bowel obstruction.
- Ongoing treatment with immunosuppressants or systemic corticosteroids (\>10 mg/day prednisone or equivalent) within 2 weeks prior to the first dose.
- Presence of any active autoimmune disease or a history of autoimmune diseases likely to recur (including but not limited to interstitial pneumonitis, uveitis, colitis, hepatitis, hypophysitis, nephritis...
- History of acute exacerbation of chronic obstructive pulmonary disease or other respiratory disease requiring hospitalization within 1 month prior to enrollment; patients with active tuberculosis or those who received...
- HIV positive; or positive HBsAg with quantifiable HBV DNA ≥1000 cps/mL; or positive anti-HCV antibody.
- Receipt of live vaccines within 4 weeks prior to first dose or anticipated during the study period.
- Positive pregnancy test or currently breastfeeding.
- Women of childbearing potential or sexually active men who are unwilling or unable to use medically accepted methods of contraception during the study period.
- Any condition, as determined by the investigator, that may interfere with the study results or patient safety, such as substance abuse, serious physical or mental illness requiring concurrent treatment, significant...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
- Zhongshan, Guangdong, China
- Zhuhai, Guangdong, China
- Changsha, Hunan, 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 all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China; Zhongshan, Guangdong, China; Zhuhai, Guangdong, China; Changsha, Hunan, 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.