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Compares treatment options for Metastatic Clear Cell Renal Cell Carcinoma
Official title Comparing the Outcome of Immunotherapy-Based Drug Combination Therapy With or Without Surgery to Remove the Kidney in Metastatic Kidney Cancer, the PROBE Trial
ClinicalTrials.gov ID: NCT04510597
What this study is testing
What is Active Comparator?
Active Comparator is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for metastatic clear cell renal cell carcinoma.
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
- This phase III trial compares the effect of adding surgery to a standard of care immunotherapy-based drug combination versus a standard of care immunotherapy-based drug combination alone in treating patients with kidney cancer that has spread to other places in the body (metastatic). Immunotherapy with monoclonal antibodies, such as nivolumab, ipilimumab, pembrolizumab, and avelumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
- Phase 3: a large, late-stage study
- Time commitment: about 7 years
- 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
- STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with...
- STEP 1 REGISTRATION: Participants must have primary tumor in place
- STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic...
- Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)
- CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast Scans must be performed...
You likely can't join if
- STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if...
- STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:
- Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended...
- Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off...
- STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:
- Treatment naive participants must not have received any pre-randomization treatment.
See the full eligibility criteria
Who can join
- STEP 1 REGISTRATION: Participants must have a histologically proven diagnosis of clear cell or non-clear cell renal cell carcinoma. Participants with collecting duct carcinoma histology are not eligible. Participants...
- STEP 1 REGISTRATION: Participants must have primary tumor in place
- STEP 1 REGISTRATION: Participants must have the following scans performed, showing clinical evidence of measurable or non-measurable metastatic disease:
- Computed tomography (CT) scan of the chest (can be performed without contrast if CT contrast cannot be given)
- CT of abdomen and pelvis with contrast OR magnetic resonance imaging (MRI) of the abdomen and pelvis with or without contrast Scans must be performed within the following timeframes:
- Treatment naive participants must have scans documenting metastatic disease completed within 90 days prior to study registration
- Previously treated participants must have scans documenting metastatic disease completed within 90 days prior to first dose of systemic treatment
- STEP 1 REGISTRATION: Participants with symptomatic metastases may have received palliative radiotherapy or receive palliative radiotherapy after registration
- STEP 1 REGISTRATION: Participants must have no clear contraindications to nephrectomy
- STEP 1 REGISTRATION: Participants must be offered the opportunity to participate in specimen bank. With participant consent, specimens must be collected and submitted via the Southwest Oncology Group (SWOG) Specimen...
- STEP 1 REGISTRATION: Participants must be informed of the investigational nature of this study and must sign and give informed consent in accordance with institutional and federal guidelines
- STEP 1 REGISTRATION: As part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of...
- STEP 2 REGISTRATION: Participants must have at least one of the following scans performed 12 weeks (+/- 2 weeks) after starting pre-randomization treatment
- CT scan of the chest (can be performed without contrast if CT contrast cannot be given)
- CT of abdomen and pelvis with contrast OR MRI of the abdomen and pelvis with or without contrast Scans must be performed within 28 days prior to randomization. Response should be assessed by comparing with a CT or MRI...
- STEP 2 REGISTRATION: Participants must have one of the following objective statuses after 12 weeks of pre-randomization treatment
- Stable disease
- Partial response
- The treating investigator believes the patient is deriving clinical benefit from systemic therapy AND have Zubrod performance status 0-1
- STEP 2 REGISTRATION: Participants must plan to continue the immune-based therapy received during pre-randomization treatment
- STEP 2 REGISTRATION: Participants must be assigned by chance on or between the 11th and 14th week of protocol-directed pre-randomization treatment therapy
- STEP 2 REGISTRATION: Participants must have received at least one of the minimum amounts of immunotherapy:
- 2 infusions of nivolumab + 1 infusion of ipilimumab
- 2 infusions of pembrolizumab
- 2 infusions of avelumab
- STEP 2 REGISTRATION: Participants must have a planned surgery date within 42 days of randomization
- STEP 2 REGISTRATION: Participants must be a surgical candidate as determined by study urologist. The urology consult should be done within 42 days prior to randomization
- STEP 2 REGISTRATION: Participants must have a complete physical examination and medical history within 28 days prior to randomization
- STEP 2 REGISTRATION: Participants must have a Zubrod performance status of 0-1 within 28 days prior to randomization
- STEP 2 REGISTRATION: Total bilirubin =\< institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- STEP 2 REGISTRATION: Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 3 x institutional upper limit of normal (ULN) (within 28 days prior to randomization)
- STEP 2 REGISTRATION: Serum creatinine =\ = 50 mL/min using the Cockcroft-Gault Formula) (must have been drawn and processed within 28 days prior to randomization)
What rules you out
- STEP 1 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain...
- STEP 1 REGISTRATION: Participants must not have received the following prior treatment of metastatic renal cell carcinoma:
- Treatment naive participants must not have received any prior lines of systemic therapy for metastatic renal cell carcinoma beyond the line intended as part of protocol therapy
- Previously treated participants must not have received any systemic therapy for metastatic renal cell carcinoma beyond the one regimen received off protocol as specified in Step 1 pre-randomization treatment
- STEP 1 REGISTRATION: Participants must not have received more than the following amounts protocol-directed pre-randomization treatment:
- Treatment naive participants must not have received any pre-randomization treatment.
- Previously treated participants must not be planning to receive any additional treatment prior to Step 2 randomization, and must not have received more than the following amounts of pre-randomization treatment:
- 4 infusions of nivolumab
- 4 infusions of ipilimumab
- 4 infusions of pembrolizumab
- 7 infusions of avelumab
- STEP 1 REGISTRATION: Participants must not have received immunotherapy for any cancer within the following timeframes:
- Treatment naive participants must not have received any immunotherapy within a year of registration
- Previously treated participants must not have received any other immunotherapy within a year of the start of off protocol specified pre-randomization treatment
- STEP 1 REGISTRATION: Participants must not have a solitary kidney and not have a transplanted kidney
- STEP 1 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, any in situ or T1 cancer, adequately treated stage I or II cancer from...
- STEP 1 REGISTRATION: Participants must not have been previously diagnosed with a medical condition that makes them ineligible for immune based combination therapy or nephrectomy
- STEP 2 REGISTRATION: Participants must not show progression in the primary tumor. Participants who are considered to have pseudo progression are allowed
- STEP 2 REGISTRATION: Participants must not have known active brain metastases. Participants with previously treated brain metastases are eligible if participant has no neurologic signs or symptoms suggestive of brain...
- STEP 2 REGISTRATION: No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which...
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Gilbert, Arizona, United States
- Kingman, Arizona, United States
- Tucson, Arizona, United States
- Fort Smith, Arkansas, United States
- Arroyo Grande, California, United States
- Auburn, California, United States
- Berkeley, California, United States
- Buena Park, California, United States
- Cameron Park, California, United States
- Castro Valley, California, United States
- Davis, California, United States
- Duarte, California, United States
- Fremont, California, United States
- Huntington Beach, California, United States
- Los Angeles, California, United States
- Modesto, California, United States
- Mountain View, California, United States
- Newport Beach, California, United States
- Novato, California, United States
+ 245 more site(s).
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 7 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 and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Gilbert, Arizona, United States; Kingman, Arizona, United States; Tucson, Arizona, United States; Fort Smith, Arkansas, United States; Arroyo Grande, California, United States and 259 more location(s). 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.