BridgeMD
New treatment option for Advanced Clear Cell Renal Carcinoma (Ccrcc)
Official title Palbociclib and Sasanlimab for the Treatment of Advanced Clear Cell Renal Cell Carcinoma (ccRCC) or Papillary Renal Cell Carcinoma (pRCC)
ClinicalTrials.gov ID: NCT05665361
What this study is testing
What is Sasanlimab?
Sasanlimab is an investigational medicine, given as an once-daily injection under the skin, being studied as a potential treatment for advanced clear cell renal carcinoma (ccrcc).
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
- Background: Kidney cancer is the 12th leading cause of cancer-related death in the United States. Some kidney tumors do not respond well to current treatments.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 2 years
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 100
You may be able to join if
- Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal...
- Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1.
- Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF...
- Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC
- Age \>= 18 years
You likely can't join if
- Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy, treatment with an experimental agent, and/or radiation therapy within 4...
- More than four prior lines of systemic therapy in the metastatic setting
- Participants who have wound dehiscence from prior surgeries
- Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might...
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents
- Prior history of grade \>=3 immune-related adverse event(s) with checkpoint inhibitor therapy. Note: participants who had endocrine toxicity of...
See the full eligibility criteria
Who can join
- Cytologically or histologically confirmed clear cell renal cell carcinoma (presence of a clear cell component) (ccRCC) (Cohort 1) or papillary renal cell carcinoma (pRCC) (presence of a papillary component) (Cohort 2)
- Participants must have advanced RCC with at least one measurable lesion as outlined in RECIST 1.1.
- Participants with ccRCC (Cohort 1) must have received checkpoint inhibitor therapy and must have received or been ineligible to receive a VEGF pathway antagonist (as a single agent or as part of a combination)
- Participants with pRCC (Cohort 2) can be treatment-na(SqrRoot) ve or have previously received systemic treatment for pRCC
- Age \>= 18 years
- ECOG performance status \<= 1
- Adequate hematologic function at screening, as follows:
- Absolute neutrophil count (ANC) \>= 1,000/microliter
- Hemoglobin (Hb) \>= 9 g/dL with no blood transfusion within 2 weeks prior to treatment initiation
- Platelets \>= 100,000/microliter
- Adequate renal and hepatic function at screening, as follows:
- Serum creatinine \ 1.5x ULN, creatinine clearance (CrCl) \>= 30 mL/min/1.73 m\^2 (calculated CrCl (CKD-EPI or calculated eGFR provided by laboratory))
- Total bilirubin \<= 1.5 x ULN OR in participants with known or suspected Gilbert's syndrome, total bilirubin \<= 3.0 x ULN
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<= 2.5 x ULN, (unless liver metastases are present, then values must be \<= 5 x ULN)
- Participants serologically positive for hepatitis C virus (HCV) are eligible if HCV viral load is undetectable
- Participants serologically positive for human immunodeficiency virus (HIV) are eligible if they are on stable antiretroviral therapy for at least 4 weeks before treatment initiation, have no reported opportunistic...
- Participants with brain metastasis are eligible if at least 4 weeks status post radiotherapy or surgery before treatment initiation with no evidence of progression or associated symptoms
- Women of child-bearing potential (WOCBP) must agree to use one (1) highly effective method of contraception (e.g.,hormonal, intrauterine device (IUD), surgical sterilization) prior to study entry, for the duration of...
- Men with female partners of reproductive potential and pregnant partners are required to use a condom (even after vasectomy), during treatment and for at least 6 months after the final dose and must refrain from...
- Breastfeeding participants must be willing to discontinue breastfeeding from study enrollment through 6 months after study treatment discontinuation
- Participants must be able to understand and be willing to sign a written informed consent document
What rules you out
- Prior treatment for RCC with chemotherapy, hormonal therapy, immunotherapy, treatment with an experimental agent, and/or radiation therapy within 4 weeks or 5 halflives, whichever is shorter, prior to treatment...
- More than four prior lines of systemic therapy in the metastatic setting
- Participants who have wound dehiscence from prior surgeries
- Active inflammatory bowel disease, chronic diarrhea, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of palbociclib
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study agents
- Prior history of grade \>=3 immune-related adverse event(s) with checkpoint inhibitor therapy. Note: participants who had endocrine toxicity of grades 3 or 4 are eligible
- An active autoimmune disease. Note: participants with type 1 diabetes, eczema, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease, adrenal insufficiency on systemic oral corticosteroid therapy (\<= the...
- Participants receiving systemic corticosteroids at doses equivalent \> 10 mg/daily of prednisone, cyclophosphamide, azathioprine, methotrexate, mycophenolate mofetil, sirolimus, thalidomide, or anti-tumor necrosis...
- Prior allogeneic/autologous bone marrow or solid organ transplant
- Participants with current or past hepatitis B (HBV) infection
- Participants with a history of interstitial lung disease, non-infectious pneumonitis, or untreated active/latent pulmonary tuberculosis (TB)
- Participants taking medications that are strong inhibitors or inducers of CYP3A...
- Participants taking any herbal supplements within 14 days prior to initiation of study therapy
- History of a non RCC malignancy within 2 years of treatment initiation except for the following: adequately treated localized skin cancer, ductal carcinoma in situ, cervical carcinoma in situ, superficial bladder...
- Pregnant women (confirmed by beta-HCG serum pregnancy test performed at screening)
- Uncontrolled intercurrent illness that would limit compliance with study requirements, evaluated by history, physical exam, and chemistry panel.
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, 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 study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, 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.