BridgeMD
New treatment option for Renal Insufficiency
Official title DV Combined With Toripalimab for Renal Preservation in Solitary Kidney or Renal Insufficiency or Bilateral Multiple UTUC
ClinicalTrials.gov ID: NCT06354231
What this study is testing
What is DV?
DV is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for renal insufficiency.
Also referred to as RC48.
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
- Approximately 20 participants will be enrolled in the study to evaluate the efficacy and safety of the combination of DV (DV, 2.0 mg/kg, intravenously administered every 2 weeks) and toripalimab (toripalimab, 3.0mg/kg, intravenously administered every 2 weeks). Subjects will receive 6 cycles of DV and toripalimab, followed by laser surgery to remove ureteral or renal pelvis tumors, followed by 12 cycles of DV and 1 year of toripalimab consolidation therapy.
- 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 and older
You may be able to join if
- ≥18 years old;
- Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;
- Refusal or ineligibility for RNU;
- Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the following factors:
- Hydronephrosis;
You likely can't join if
- Histopathological examination revealed any small cell component of ureter or pelvis, simple adenocarcinoma, simple squamous cell carcinoma, or simple...
- Previous treatment with other PD-1/PD-L1 inhibitors and/or HER-2 inhibitors;
- Active malignancies other than the disease being studied for treatment (i.e., disease progression within the last 24 months or requiring a change in...
- History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina pectoris, myocardial...
- Pregnant or lactating women;
- Human immunodeficiency virus (HIV) infection is known unless the subject has been on stable antiretroviral therapy for the past 6 months or longer...
See the full eligibility criteria
- ≥18 years old;
- Histologically confirmed isolated renal or renal insufficiency or bilateral upper urinary tract urothelial carcinoma;
- Refusal or ineligibility for RNU;
- Preoperative risk stratification was defined as high-risk UTUC, defined as patients with any of the following factors:
- Hydronephrosis;
- Tumor diameter ≥2cm;
- Urine cytology suggests a high-grade tumor;
- A ureteroscopic biopsy suggests a high-grade tumor;
- CT showed a localized invasion;
- Multifoci diseases;
- With multiple histological subtypes;
- ECOG 0\~1;
- Major organ function is normal (14 days prior to enrollment) if the following criteria are met:
- The blood routine examination criteria should meet (no blood transfusion and no granulocyte colony stimulation agent treatment within 14 days before enrollment): HB≥90 g/L; ANC≥1.5×109 /L; PLT≥100×109 /L;
- Non-functional organic diseases shall meet the following criteria: T-BIL≤1.5×ULN (upper limit of normal value); ALT and AST≤2.5 x ULN; Serum creatinine ≤2×ULN, or endogenous creatinine clearance ≥...
- people (or their legal representatives) must sign an informed consent form (ICF) indicating that they understand the purpose and procedures of the study and are willing to participate in the study.
- Pregnant women must have a negative pregnancy test result (beta-hCG) (urine or serum) within 7 days before the first administration of the assigned by chance or study drug.
- Histopathological examination revealed any small cell component of ureter or pelvis, simple adenocarcinoma, simple squamous cell carcinoma, or simple squamous CIS;
- Previous treatment with other PD-1/PD-L1 inhibitors and/or HER-2 inhibitors;
- Active malignancies other than the disease being studied for treatment (i.e., disease progression within the last 24 months or requiring a change in treatment), only the following special cases are allowed: i. Skin...
- History of uncontrolled cardiovascular disease, including: 1) any of the following in the past 3 months: unstable angina pectoris, myocardial infarction, ventricular fibrillation, torsion ventricular tachycardia...
- Pregnant or lactating women;
- Human immunodeficiency virus (HIV) infection is known unless the subject has been on stable antiretroviral therapy for the past 6 months or longer, has not developed an opportunistic infection in the past 6 months, and...
- Known history of clinically significant liver disease, including viral hepatitis [active HBV infection, i.e., HBV DNA positive (\>1×104 copies /mL or \>2000 IU/ml) must be excluded for known hepatitis B virus (HBV)...
- Have not recovered from the toxic effects of previous anticancer treatment (except for those that are not clinically significant, such as hair loss, skin discoloration, neuropathy, and hearing impairment);
- Delayed wound healing, defined as skin/bedsore ulcers, chronic leg ulcers, known stomach ulcers, or non-healing of incisions;
- Major surgery within 4 weeks before day 1 of Cycle 1 (TURBT is not considered a major surgery);
- Other patients assessed by the investigator as unsuitable for participation in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, 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.