AzTrials
AzTrials

Advanced CancerPhase 1/2NCT05663710

Phase 1b/2 Study of Combination 177Lu Girentuximab Plus Cabozantinib and Nivolumab in Treatment naïve Patients With Advanced Clear Cell RCC

A Phase 1/2 study testing 177Lu girentuximab, Nivolumab and Cabozantinib in people with Advanced Cancer and Clear Cell Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
177Lu girentuximab, Nivolumab and Cabozantinib
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteUnited States
Study dates
30 Jun 2023to 30 Oct 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 16Show fewer
  • 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 obtaining the hematology values at screening; b. Creatinine clearance ≥ 40 mL/min/1.73m2 c. Transaminase levels (AST/ALT) ≤ 3.0 × upper limit of normal (ULN); total bilirubin i. (TBILI) ≤ 1.5 mg/dL in the absence of Gilbert's disease
  • 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 method of contraception during screening, during the period of drug administration and for 120 days after stopping study drug administration. Highly effective contraception methods include the following:
  • 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 hormonal contraception associated with inhibition of ovulation ii. Progestogen-only hormonal contraception associated with inhibition of ovulation c. Placement of an intrauterine device or intrauterine system
  • 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.

Who cannot join

  • 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
Show all 25Show fewer
  • 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 treatment. Patients with clinically relevant ongoing major complications from prior radiation therapy are not eligible.
  • 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, pulmonary embolism, clinically significant ventricular arrhythmias (e.g. sustained ventricular tachycardia, ventricular fibrillation, torsades de pointes) or New York Heart Association Class III or IV heart failure
  • 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 opinion of the investigator or medical monitor
  • 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 biliary duct, or gastric outlet obstruction
  • 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 confirmed before administration of the first dose of study treatment
  • 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 first study drug administration and from minor surgery (e.g., simple excision, tooth extraction) at least 10 days before the first study drug administration. Patients with clinically relevant ongoing complications from prior surgery are not eligible
  • 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 patient has remained disease free for more than 2 years.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eric Jonasch, MD contact

(713) 563-7232

ejonasch@mdanderson.org

United States1 site, 1 recruiting

  • MD Anderson Cancer Center

    Houston, Texas, 77030

    Eric Jonasch, MD, 713-563-7232, ejonasch@mdanderson.org

    Eric Jonasch, MD

    Recruiting

Other trials in United States

About this study

To learn if giving 177Lu girentuximab in combination with cabozantinib plus nivolumab can help to control advanced clear cell renal cell carcinoma (ccRCC).

Read the detailed description

Primary Objectives:

  • To determine safety of combination 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC.
  • To evaluate CR rate in the combination of 177Lu girentuximab with nivolumab plus cabozantinib in subjects with previously untreated ccRCC. 2. CR rate by RECIST 1.1 by investigator

Secondary Objectives:

  • To evaluate ORR of 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC.
  • To evaluate PFS of 177Lu girentuximab in combination with nivolumab plus cabozantinib in subjects with previously untreated ccRCC.
Being tested
177Lu girentuximab, Nivolumab, Cabozantinib, ArabinoFuranosylGuanine [18F]F-AraG
Medical subject headings
Carcinoma, Renal Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu girentuximabDrug

    Given by IV (vein)

  • NivolumabDrug

    Also called BMS-936558, Opdivo

    Given by IV (vein)

  • CabozantinibDrug

    Also called XL-184, XL184

    Given by PO

  • ArabinoFuranosylGuanine [18F]F-AraGDrug

    Given by IV (vein)

Study groups in NCT05663710
Study groupRoleWhat they receive
Cohort 1 (Biopsy)ExperimentalParticipants within 2 weeks of starting the first dose of 177Lu-girentuximab
Receives: Drug: 177Lu girentuximab; Drug: Nivolumab; Drug: Cabozantinib; Drug: ArabinoFuranosylGuanine [18F]F-AraG
Cohort 2 (Biopsy)ExperimentalParticipants within 2 weeks of Cycle 4
Receives: Drug: 177Lu girentuximab; Drug: Nivolumab; Drug: Cabozantinib; Drug: ArabinoFuranosylGuanine [18F]F-AraG
Cohort 3 (Biopsy)ExperimentalParticipants at the time of progression or at 20 months post treatment
Receives: Drug: 177Lu girentuximab; Drug: Nivolumab; Drug: Cabozantinib; Drug: ArabinoFuranosylGuanine [18F]F-AraG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: through study completion; an average of 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2022
  2. Study start30 Jun 2023
  3. Primary completion30 Oct 2027 (estimated)
  4. Study completion30 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05663710
Sponsor's protocol ID
2021-0911
Other IDs
NCI-2022-10595, CDMRP-KC210253
Status last verified
Oct 2026
First submitted
15 Dec 2022
Last updated
3 Nov 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing 177Lu girentuximab, Nivolumab and Cabozantinib in people with Advanced Cancer and Clear Cell Renal Cell Carcinoma, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eric Jonasch, MD ((713) 563-7232, ejonasch@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05663710.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in