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New treatment option for Advanced Cancer
Official title Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC
ClinicalTrials.gov ID: NCT05663710
What this study is testing
What is 177Lu girentuximab?
177Lu girentuximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for advanced 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
- To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).
- 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 and older
You may be able to join if
- Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and...
- Age ≥ 18 years
- Has locally advanced or metastatic RCC with predominantly clear cell subtype
- Has at least one measurable lesion as defined by RECIST version 1.1
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
You likely can't join if
- Has received treatment with any frontline systemic therapy for metastatic RCC
- Has a history of leptomeningeal disease or spinal cord compression
- Has a history of autoimmune disease requiring active therapy
- Has a history of brain metastases except:
- Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g...
- Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs
See the full eligibility criteria
- Has the ability to understand and willingness to sign a written ICF before the performance of any study-specific procedures on this protocol and 2022-0515
- Age ≥ 18 years
- Has locally advanced or metastatic RCC with predominantly clear cell subtype
- Has at least one measurable lesion as defined by RECIST version 1.1
- Has an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
- Has adequate organ function defined as follows: a. Absolute neutrophil count ≥ 1,500/µL, Hgb level ≥ 9 g/dL and platelet count (Plt) i. ≥ 100,000/µL without transfusion or growth factor support within 2 weeks prior to...
- Women of child beariring potential must have a negative serum preganancy test within 7 days before first study drug administration
- Female patients of child bearing potential, or a male patients with a female partner of child-bearing potential (defined as all women physiologically capable of becoming pregnant), must agree to use a highly effective...
- Total abstinence (defined as refraining from heterosexual intercourse during the entire period outlined above),
- Male or female sterilization, or Use of at least one of the following: Use of oral, injectable, transdermal, intravaginal, or implantable hormonal methods of contraception i. Combined estrogen and progestogen containing...
- Able to swallow oral medications
- Able to provide tumor tissue sample (archival or recent acquisition)
- Patients with brain metastases are eligible providing other measurable disease exists and brain lesions are controlled for one month (requiring no therapy) and are not life threatening.
- Has received treatment with any frontline systemic therapy for metastatic RCC
- Has a history of leptomeningeal disease or spinal cord compression
- Has a history of autoimmune disease requiring active therapy
- Has a history of brain metastases except:
- Patients may be enrolled if they have treated brain metastases with no evidence of progression or hemorrhage after therapy for brain metastases (e.g. radiation therapy, surgery, radiosurgery) AND
- Patients may be enrolled if they do not require ongoing treatment with dexamethasone or anti-epileptic drugs
- Has had radiation therapy for bone metastases within 2 weeks, or any other external radiation therapy (5 days or longer) to sites other than bone, within 4 weeks before administration of the first dose of study...
- Has uncontrolled or poorly controlled hypertension, as defined by a sustained blood pressure (BP) \> 140/90 with or without antihypertensive treatment
- Has had any major cardiovascular event within 6 months prior to study drug administration including but not limited to myocardial infarction, unstable angina, cerebrovascular accident, transient ischemic attack...
- Has any other clinically significant cardiac, respiratory, or other medical or psychiatric condition that might interfere with participation in the trial or interfere with the interpretation of trial results, in the...
- Has an active infection requiring systemic treatment
- Is participating in another therapeutic clinical trial
- Is receiving chronic concomitant treatment with strong CYP3A4 inducers or CYP3A4 inhibitors
- Has manifestations of malabsorption due to prior gastrointestinal (GI) surgery or GI disease
- Has GI disorders including those associated with a high risk of perforation or fistula formation:
- Tumors invading the GI-tract, active peptic ulcer disease, inflammatory bowel disease, diverticulitis, cholecystitis, symptomatic cholangitis or appendicitis, acute pancreatitis or acute obstruction of the pancreatic or...
- Abdominal fistula, GI perforation, bowel obstruction, or intra-abdominal abscess within 6 months before administration of the first dose of study treatment. Note: complete healing of an intra-abdominal abscess must be...
- Has tumor invading or encasing any major blood vessels
- Has other clinically significant disorders such as:
- Serious non-healing wound/ulcer/bone fracture
- Moderate to severe hepatic impairment (Child-Pugh B or C).
- Requirement for hemodialysis or peritoneal dialysis
- History of solid organ transplantation
- Has had major surgery (e.g., GI surgery, removal or biopsy of brain metastasis) within 2 months before the first study drug administration. Complete wound healing from major surgery must have occurred 1 month before the...
- Has a prior or concomitant invasive malignancy other than RCC with the exception of adequately treated basal or squamous cell carcinoma of the skin, cervical carcinoma in situ or any other malignancy from which the...
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. 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.