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Collecting Duct CarcinomaPhase 2NCT06211114

Study to Evaluate the Efficacy and Safety of Immunotherapy With Axitinib in Advanced Collecting Duct Carcinoma

A Phase 2 study testing PD-(L)1 inhibitor and Axitinib in people with Collecting Duct Carcinoma, run by Peking University Cancer Hospital & Institute at 2 sites in China.

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

This is a phase II trial to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with axitinib for previously treated advanced collecting duct carcinoma. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Collecting Duct Carcinoma
What is being tested?
PD-(L)1 inhibitor and Axitinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
2 sitesChina
Study dates
9 Feb 2024to Feb 2027
Phase
Phase 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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Fully understand and be willing to provide written informed consent.
  • Male or female with age ≥ 18 years and <80 years.
  • Have received prior systemic therapy after previous metastasis for collecting duct carcinoma, histologically confirmed diagnosis of unresectable, recurrent or metastatic collecting duct carcinoma.
  • Having at least one measurable disease per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if re-progression has been demonstrated.
  • ECOG PS 0 or 1.
  • Adequate function of vital organs:
Show all 35Show fewer
  • 6.1 Bone marrow function (without blood or blood products transfusion, without hematopoietic stimulating factor or other medication to improve blood cell count within 2 days prior to first dose of study drug): Absolute neutrophil count (ANC) ≥ 1.5×109/L. Platelets ≥ 100×109/L. Hemoglobin ≥ 9.0g/dL or ≥ 5.6mmol/L. 6.2 Renal function: Serum creatinine ≤ 1.5×ULN 6.3 Hepatic function:Serum total bilirubin ≤1.5×ULN or total bilirubin levels >1.5×ULN with direct bilirubin ≤ ULN. AST and ALT ≤2.5 × ULN, ≤5×ULN in those with hepatic metastasis.
  • 6.4 Endocrine function: Normal thyroid stimulating hormone, or abnormal TSH whilst normal FT3 and FT4.
  • 6.5 Coagulation function: International normalized ratio (INR) or prothrombin time (PT) ≤1.5×ULN, and activated partial thromboplastin time (aPTT) ≤1.5×ULN, Subjects receiving anticoagulant therapy (e.g., heparin or warfarin) may participate in the study with PT or APTT levels within the scope of the proposed therapy and monitored during study treatment.
  • 6.6 Left ventricular ejection fraction (LVEF) ≥ 50%.
  • Being willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
  • Female subjects of childbearing potential must have a negative serum pregnancy test within 7 days prior to the first treatment dose. Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must agree to use a highly effective methods of contraceptive throughout the study and for 180 days after the last dose of study therapy.
  • Exclusion Criteria: Exclusion criteria: Patients with any of the following conditions will not be included in the study:
  • Prior Anti-PD-1, PD-L1 or axitinib.
  • Has participated or is currently participating in a trial of investigational agent within 4 weeks prior to the first dose of study treatment, unless observational (non-interventional) clinical study or follow-up period of interventional study.
  • Had major surgery (judged by investigators) within 4 weeks prior to the first dose of study treatment or has not recovered from prior surgery.
  • Has traditional Chinese medicine or Chinese patent medicine preparation with anti-cancer indication within 2 weeks prior to the first dose of study treatment.
  • Requiring corticosteroids (Prednisone >10 mg/day or equivalent analogue) or other immunosuppressive agents within 2 weeks prior to the first dose of study treatment. 6. Patients without active autoimmune disease using inhaled prednisone >10 mg/day will not be excluded from the study.
  • 7. Has a history of organ transplantation or required long-term treatment with corticosteroids.
  • 8. Hypothyroidism, hypoadrenalism or hypopituitarism that can be controlled only with hormone replacement therapy, type I diabetes, psoriasis or leucoderma not requiring systematic treatment.
  • 9. Not recovered from the toxicity of prior anti-cancer therapy, i.e., not recovered to baseline, Grade 0-1 (NCI-CTCAE 5.0, except alopecia) or per inclusion/exclusion criteria in protocol. Under rational expectation, irreversible toxicities (e.g., hearing loss) which will not be worsened by study treatments may be enrolled in the study.
  • 10. Has an additional malignancy that has progressed or required treatment within 5 years prior to randomization (basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ such as breast cancer, prostate cancer are acceptable if they have undergone potentially curative therapy；Remarks: Localized low-risk prostate cancer [ patietns with stage ≤ T2a, Gleason score ≤ 6 and PSA < 10ng/mL at the time of diagnosis (as measured) can be included in this study if the subject has received radical therapy and has no evidence for biochemical recurrence(PROSTATE specific antigen,PSA)].
  • 11. Has a history of active central nervous system (CNS) metastasis or CNS metastasis had been confirmed by radiological examination (MRI or CT) at baseline within 30 days prior to the first dose of study drug. Subjects may participate who had been stable at least for 3 months after prior surgery or RT for brain or meningeal metastasis and discontinued systemic treatment with corticosteroids (Prednisone >10 mg/day or equivalent analogue) for at least 4weeks. Subjects may participate in the study if their CNS metastases are adequately treated to meet the requirements specified in the inclusion criteria, and their neurological symptoms recover to grade 0-1 (CTCAE 5.0) for at least 2 weeks prior to inclusion (except for residual signs or symptoms associated with CNS treatment).
  • 12. Poorly controlled hypertension (systolic blood pressure ≥ 150mmHg and/or diastolic blood pressure ≥ 90mmHg).
  • 13. Presence of the following cardiovascular events within 6 months prior to randomization: Myocardial infarction Unstable angina pectoris Cardiac angioplasty or stent Coronary/peripheral artery bypass graft Grade III or IV congestive heart failure per New York Heart Association Cerebrovascular accident or transient ischemic attack QT interval (QTc) ≥ 480 msec corrected with heart rate (Bazett's formula); 14. Has active hemorrhage or history of other significant hemorrhage episodes within 30 days prior to randomization.
  • 15. Has deep vein thrombosis or pulmonary embolism within 6 months prior to randomization.
  • 16. Has arterial thrombosis within 12 months prior to randomization. 17. Has clinically significant gastrointestinal (GI) abnormalities including: Malabsorption, total gastrectomy or any other condition that might affect the absorption of orally taken medication.
  • Active ulcer under treatment in the past 6 months; Active GI bleeding (e.g., hematemesis, hematochezia or melena) in the past 3 months, and without evidence of resolution documented by endoscopy or colonoscopy.
  • Intraluminal metastatic lesion with suspected hemorrhage, inflammatory bowel disease, ulcerative colitis, GI perforation, or other GI conditions associated with increased risk of perforation.
  • 18. Has a history of or current (non-infective) pneumonia/ interstitial lung disease that required steroids.
  • 19. Has an active infection requiring systemic therapy. Has a known history of Human Immunodeficiency Virus (HIV) infection (HIV antibody positive), HBV or HCV infection (Patients with positive HBsAg or negative HBsAg, but positive HBcAb will be enrolled in the study when HBV DNA was tested in central laboratory and lower than ULN. Patients with a history of HCV infection may participate in the study if the result of HCV RNA test was negative during screening period).
  • 20. Has received a live virus vaccine within 30 days prior to randomization, including (but not limited to) mumps, rubella, measles, varicella/ herpes zoster (chicken pox), yellow fever, rabies, Bacille Calmette-Guérin (BCG) and typhoid vaccine. Inactivated virus vaccines are allowed.
  • 21. Has a history of hypersensitivity reaction, including (but not limited to) antibodies and TKIs.
  • 22. Known history of psychiatric disorders or drug abuse. 23. Has evidence of inadequate wound healing. 24. Has current use (within 7 days of randomization) or anticipated need for treatment drugs what are known strong CYP3A4/5 inhibitor and CYP3A4/5 inducer (including, but not limited to, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin and St. John's wort) or the drugs that are known with proarrhythmic potential (including, but not limited to, terfenadine, quinidine, procainamide, disopyramide, sotalol, probucol and benazapril, etc.).
  • 25. Has a history or current evidence on any condition, therapy or laboratory abnormality that might confound the results of the study, interfere with subject's participation for the full duration of the study, or is not in the best interest of subject to participate, in the opinion of investigators.

Who cannot join

None listed.

Trial locations and contacts

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

Xinan Sheng, MD. contact

+86-10-88196348

doctor_sheng@126.com

China2 sites, 2 recruiting

  • Department of Genitourinary Oncology, Peking University Cancer Hospital & Institute

    Beijing, Beijing Municipality, 100000

    Xinan Sheng, Dr., +86-10-88196348, doctor_sheng@126.com

    Xinan Sheng, Dr.

    Recruiting

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100086

    Xinan Sheng, MD., +86-10-88196348, doctor_sheng@126.com

    Xieqiao Yan, MD.

    Not yet recruiting

Other trials in China

About this study

Official title: Study to Evaluate the Efficacy and Safety of Immune Checkpoint Inhibitors in Combination With Axitinib in Previously Treated Advanced Collecting Duct Carcinoma

This is a phase II trial to evaluate the efficacy and safety of immune checkpoint inhibitors in combination with axitinib for previously treated advanced collecting duct carcinoma.

Read the detailed description

Patients meeting specific inclusion and exclusion criteria will be enrolled in two stages, 8 patients in stage 1 and 22 patients in stage 2. Stage 2 will enroll if 1 or more patients exhibit a response at week 9 or later in stage 1 in the study. All enrolled patients will be treated with immune checkpoint inhibitors in combination with axitinib until disease progression. Efficacy will be assessed by tumor measurements using CT and MRI (when indicated) scans and physical exam at baseline, and scans and physical exam of all disease-involved areas every 9 weeks until progression. Safety will be assessed by periodic physical exams, clinical laboratory studies, and adverse events. All patients will have a follow-up visit 90 days following last study drug treatment.

Being tested
PD-(L)1 inhibitor, Axitinib
Keywords
Immune Checkpoint Inhibitors, Axitinib
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.

  • PD-(L)1 inhibitorDrug

    Toripalimab 240mg or Tirelizumab 200mg or pembrolizumab 200mg intravenously every 3 weeks

  • AxitinibDrug

    axitinib 5mg orally twice daily

Study groups in NCT06211114
Study groupRoleWhat they receive
PD-(L)1 inhibitor + AxitinibExperimentalImmune Checkpoint Inhibitors in Combination With Axitinib
Receives: Drug: PD-(L)1 inhibitor; Drug: Axitinib

What is being measured

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

  1. ORR assessed by investigators per RECIST 1.1

    The treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response.

    Measured: Up to approximately 2 years

Secondary outcomes (1)

  1. PFS assessed by investigators per RECIST 1.1

    The treatment effect of with ICI plus axitinib will be assessed using RECIST 1.1 to determine tumor response.

    Measured: Up to approximately 2 years

Timeline

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

  1. First posted18 Jan 2024
  2. Study start9 Feb 2024
  3. Primary completionFeb 2026 (estimated)
  4. Study completionFeb 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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06211114
Sponsor's protocol ID
FD-001-II-RCC
Status last verified
Nov 2024
First submitted
8 Jan 2024
Last updated
26 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-(L)1 inhibitor and Axitinib in people with Collecting Duct Carcinoma, run by Peking University Cancer Hospital & Institute at 2 sites in China.

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 35 inclusion and 0 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 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 phase mean?

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 Xinan Sheng, MD. (+86-10-88196348, doctor_sheng@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ORR assessed by investigators per RECIST 1.1 (time frame: Up to approximately 2 years). 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 NCT06211114.

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 26 Nov 2024.

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