Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

  • STATUS
    Recruiting
  • days left to enroll
    71
  • participants needed
    30
  • sponsor
    Herlev and Gentofte Hospital
Updated on 27 January 2021

Summary

The purpose of the open-label INDIGO-study is to examine whether a first line individualized treatment strategy based on DNA and RNA analyses from the patient's tumor is feasible. Moreover, to involve the patient further in their treatment via patient-reported outcomes (PRO) measurements in a value-based healthcare setup with simultaneous analyses of the financial costs of this strategy.

The patients are assigned into 4 treatment arms according to the results of their DNA and RNA analyses. All patients receive electronic questionnaires regarding symptoms and side effects weekly and questionnaires regarding quality of life monthly. Based on each patient's answers of the questionnaires the patient receives advices in the app to reduce the symptoms and side effects or the patient is instructed to contact the hospital.

The hypothesis: Basing the choice of first-line treatment for DNA mutations and RNA profiles in a heterogeneous patient population increases the overall response rate for the total population to 30% compared to 10% for historical cohorts.

Details
Condition urinary tract neoplasm, Urologic Cancer, Malignant neoplasm of kidney, Kidney Cancer, Renal Cancer, Nephropathy, Nephropathy, Kidney Disease, Kidney Disease (Pediatric), Genitourinary Neoplasms, Genitourinary Cancer, Kidney Disease (Pediatric), Metastatic Renal Cell Carcinoma, Metastatic Kidney Cancer, Kidney Cancer, Kidney Disease, Renal Cancer, Genitourinary Cancer, Urologic Cancer, kidney neoplasm, kidney tumor, renal tumors, neoplasia renal, renal neoplasm, renal tumor, kidney tumours, kidney tumors
Treatment Medication (A specification is listed under each arm), Patient reported outcomes measurement
Clinical Study IdentifierNCT04644432
SponsorHerlev and Gentofte Hospital
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Signed informed consent form must be obtained before any study-related procedures start
The patient must be willing and able to follow the protocol
Age 18 years
Histological biopsy-confirmed inoperable, locally advanced or metastatic non-cc RCC or 100% sarcomatoid tumour arising from the kidney found unsuited for surgery with a curative intent. Nephrectomy is not mandatory
If the primary disease was diagnosed more than 1 year ago, a fresh medium needle biopsy must be collected to confirm the diagnosis and tissue must be collected for DNA and RNA analyses
If a patient with inoperable relapse had a nephrectomy less than 1 year ago, and no tissue samples are stored in Dansk CancerBiobank, a fresh medium needle biopsy must be collected for DNA and RNA analyses
In cases where metastatic disease was confirmed by biopsy more than 1 year ago without initiated treatment, the patient is offered a fresh medium needle biopsy, but this is not mandatory for inclusion
If the patient had a nephrectomy using tissue from Dansk CancerBiobank and has been diagnosed with metastases within 1 year, the patient must be offered a fresh medium needle biopsy from a metastasis if the metastasis is easily accessible for biopsy, but a fresh biopsy is not mandatory for inclusion
A medium needle biopsy is mainly taken from a metastasis, but biopsy from a renal tumour is allowed
A biopsy may not be taken from bones as it cannot be used for molecular analysis
If the primary tumour is a proven clear cell RCC, but the biopsy from a metastasis shows non-cc RCC, the patient can be included in the study
Sufficient tissue for DNA analyses, corresponding to 10 slides and RNA analyses corresponding to 1000 tumour cells
Females with a negative pregnancy test or of non-childbearing potential (menopausal, hysterectomy or ovariectomy) and non-breastfeeding
Females of childbearing potential (<2 years after last menstrual period) and males must use effective contraception (pills, intrauterine device, diaphragm or condom with spermicide or sterilisation)
Measurable disease (according to RECIST 1.1 criteria)
Karnofsky Performance status 70% / ECOG Performance status 0-2
Life expectancy more than 3 months
At baseline, the laboratory values must be: Haematology: Leukocytes 3.0 x 109/l, thrombocytes 100 x 109/l, haemoglobin 6.2 mmol/l
Biochemistry: International Normalized Ratio (INR) 1.5, APTT 1.5 x upper limit of normal (ULN) Total bilirubin 1.5 x ULN, aspartate transaminase, alanine aminotransferase 2.5 x ULN for patients without liver metastases, 5 x ULN for patients with liver metastases. Estimated glomerular filtration rate (eGFR) > 30

Exclusion Criteria

Previous systemic treatment for metastatic RCC (including neoadjuvant treatment)
Former adjuvant treatment with immune checkpoint inhibitors
Major surgical procedure, open surgical biopsy or significant trauma within 28 days prior to initiation
Serious non-healing wound, ulcer or bone fracture
Auto-immune disease or other condition requiring systemic treatment with either corticosteroids (prednisolone > 10 mg/day or similar) or other immunosuppressive drugs
Metastases in the central nervous system (CNS). The patient must have an MRI scan (preferred) or CT scan of the brain (using contrast agent if possible) within 28 prior to initiation
Seizures which cannot be managed with standard medical treatment
If urine dipstick with protein 3+, urine must be collected over a period of 24 hours which must be < 3.5 grams/day. If degree 2 proteinuria, urine must be collected over a period of 24 hours prior to each prescription
Other malignancy within 5 years (except for curatively treated basal cell carcinoma of the skin and/or cervix carcinoma in situ)
Uncontrolled hypertension ( 150 mm Hg systolic and/or 100 mm Hg diastolic) despite maximum antihypertensive medical treatment
Clinically significant (i.e. active) cardiovascular disease, such as cerebrovascular conditions ( 6 months), myocardial infarction ( 6 months), unstable angina, New York Heart Association (NYHA) congestive heart failure degree III or serious cardiac arrhythmia requiring medical treatment. Patients with well-managed Atrial fibrillation/ atrial flutter may be included
Treatment using other investigational drugs or participation in other studies
Previous or current other diseases, metabolic dysfunction, clinical findings on physical examination or clinical laboratory findings that give suspicion of a disease or condition that would contraindicate the use of an investigational drug or a patient with a high risk of treatment complications
Patients where the investigator finds that patient compliance prevents safe completion of the treatment
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