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Status unknownNCT04644432INDIGOUpdated Nov 25, 2020

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

A Phase 2 interventional study of Medication (A specification is listed under each arm) and Patient reported outcomes measurement in Metastatic Renal Cell Carcinoma, Kidney Neoplasm and Urologic Neoplasms, sponsored by Herlev and Gentofte Hospital. Status unknown at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-11-25.

Sponsored by Herlev and Gentofte Hospital · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 7 months after the study started (first participant enrolled Mar 2020, registered Oct 2020).
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Metastatic Renal Cell Carcinoma
  • Kidney Neoplasm
  • Urologic Neoplasms
  • Urogenital Neoplasms

Keywords

  • non-clear cell renal cell carcinoma
  • liquid biopsy
  • patient reported outcomes
  • gene expression
03

In context

Carcinoma

6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.

This study's planned enrollment of 30 is below the median of 45 across 5,170 interventional studies indexed under Carcinoma.

Browse Carcinoma studies →

Lead sponsor

Herlev and Gentofte Hospital is the lead sponsor of 73 studies on the registry; 25 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Signed informed consent form must be obtained before any study-related procedures start.
  2. The patient must be willing and able to follow the protocol.
  3. Age ≥ 18 years

  4. 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.

    1. 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.
    2. 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.
    3. 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.
    4. 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.
    5. A medium needle biopsy is mainly taken from a metastasis, but biopsy from a renal tumour is allowed.
    6. A biopsy may not be taken from bones as it cannot be used for molecular analysis.
    7. 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.
  5. Sufficient tissue for DNA analyses, corresponding to 10 slides and RNA analyses corresponding to 1000 tumour cells.
  6. Females with a negative pregnancy test or of non-childbearing potential (menopausal, hysterectomy or ovariectomy) and non-breastfeeding.
  7. 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).
  8. Measurable disease (according to RECIST 1.1 criteria)
  9. Karnofsky Performance status ≥ 70% / ECOG Performance status 0-2.
  10. Life expectancy more than 3 months.
  11. At baseline, the laboratory values must be: Haematology: Leukocytes ≥ 3.0 x 109/l, thrombocytes ≥ 100 x 109/l, haemoglobin ≥ 6.2 mmol/l.
  12. 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

Exclusion Criteria:

  1. Previous systemic treatment for metastatic RCC (including neoadjuvant treatment).
  2. Former adjuvant treatment with immune checkpoint inhibitors.
  3. Major surgical procedure, open surgical biopsy or significant trauma within 28 days prior to initiation.
  4. Serious non-healing wound, ulcer or bone fracture.
  5. Auto-immune disease or other condition requiring systemic treatment with either corticosteroids (prednisolone > 10 mg/day or similar) or other immunosuppressive drugs
  6. 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.
  7. Seizures which cannot be managed with standard medical treatment.
  8. 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.
  9. Other malignancy within 5 years (except for curatively treated basal cell carcinoma of the skin and/or cervix carcinoma in situ).
  10. Uncontrolled hypertension (≥ 150 mm Hg systolic and/or ≥ 100 mm Hg diastolic) despite maximum antihypertensive medical treatment.
  11. 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.
  12. Treatment using other investigational drugs or participation in other studies.
  13. 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.
  14. Patients where the investigator finds that patient compliance prevents safe completion of the treatment.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    A - for patients with a DNA mutation that match a targeted treatment

    Listed below are the possible study drugs and dosages: Erlotinib 150 mg once a day for 4 weeks. Osimertinib 80 mg once a day for 4 weeks. Alectinib 600 mg twice a day for 4 weeks Dabrafenib 150 mg twice a day combined with Trametinib 2 mg once a day for 4 weeks Trastuzumab-emtansin iv infusion 3.6 mg/kg every 3rd week Olaparib 400 mg twice a day for 4 weeks Pembrolizumab iv infusion 2 mg/kg every 3rd week Cabozantinib 60 mg once a day for 4 weeks Crizotinib 250 mg twice a day for 4 weeks Palbociclib 125 mg once a day in3 weeks, hereafter pause for one week Imatinib 400 mg once a day for 4 weeks If the patient can fit in several arms, arm A or the arm closest to arm A is chosen.

    Drug: Medication (A specification is listed under each arm) · Other: Patient reported outcomes measurement

  • Experimental
    B - for patients with an angiogen profile

    Study drug: Sunitinib peroral tablet 50 mg once a day for 4 weeks, hereafter pause for 2 weeks (4/2 schedule or 2/1 schedule). If the patient can fit in several arms, arm A or the arm closest to arm A is chosen.

    Drug: Medication (A specification is listed under each arm) · Other: Patient reported outcomes measurement

  • Experimental
    C - for patients with an immune profile

    Study drug: Nivolumab iv infusion 6 mg/kg (max 480 mg) every 4th week. If the patient can fit in several arms, arm A or the arm closest to arm A is chosen.

    Drug: Medication (A specification is listed under each arm) · Other: Patient reported outcomes measurement

  • Experimental
    D - for patients that have neither mutations nor an immune- or angiogen profile

    Study drug: Nivolumab iv infusion 6 mg/kg (max 480 mg) every 4th week. If the patient can fit in several arms, arm A or the arm closest to arm A is chosen.

    Drug: Medication (A specification is listed under each arm) · Other: Patient reported outcomes measurement

Interventions

  • DrugMedication (A specification is listed under each arm)

    Study drugs and dosages are listed in the description of arms.

  • OtherPatient reported outcomes measurement

    PRO questionnaires regarding symptoms and side effects with questions selected from the Nation Cancer Institute Patient Reported Outcomes-Common Terminology Criteria for Adverse Events. The patient receive individual advices according to the patient's answers to reduce the symptoms and side effects or is instructed to contact the hospital. For monitoring quality of life the EORTC QLQ-C30 is used. All questionnaires are in Danish.

    Also known as: PRO

06

What researchers measure

Primary outcomes

  1. Overall response rate (ORR)

    The total share of patients who have received treatment with complete and partial response assessed radiologically based on RECIST v.1.1.

    Time frame: 30 months

  2. Time to treatment failure (TTF)

    The time from start up day 1 until discontinuation of treatment, regardless of the reason.

    Time frame: 30 months

Secondary outcomes

  1. Overall Survival (OS)

    Overall survival for the total population

    Time frame: 30 months

  2. Progression-Free Survival (PFS)

    Progression-free survival for the total population

    Time frame: 30 months

  3. Disease Control Rate (DCR)

    Disease control rate (complete response + partial response + stabile disease) for the total population based on RECIST v1.1 criteria

    Time frame: 30 months

  4. Response duration

    Response duration for the total population.

    Time frame: 30 months

  5. Use of PRO tools

    The patients' use of PRO tools during treatment assessed with the validated Patient Feedback Form

    Time frame: 30 months

  6. PRO and PRO-CTCAE

    Number of and changes in Patient-reported outcomes according to PRO-CTCAE from baseline.

    Time frame: 30 months

  7. NCI-CTCAE

    Number of and types of adverse events according to NCI-CTCAE

    Time frame: 30 months

  8. Hospital admissions

    Number of hospital admissions

    Time frame: 30 months

Other outcomes

  1. Quality of life questionnaires EORTC QLQ-C30 (general quality of life questionnaire)

    Changes in quality of life measured with EORTC-C30 every 4th week during treatment

    Time frame: 36 months

07

Study locations

1 of 1 sites recruiting
08

References and documents

Publications

  • Rasmussen IML, Soerensen AV, Moller AK, Persson GF, Palshof JA, Taarnhoj GA, Pappot H. Individualizing the Oncological Treatment of Patients With Metastatic Non-Clear Cell Renal Cell Carcinoma by Using Gene Sequencing and Patient-Reported Outcomes: Protocol for the INDIGO Study. JMIR Res Protoc. 2022 Sep 15;11(9):e36632. doi: 10.2196/36632. PubMed 36107483 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04644432
Lead sponsor
Herlev and Gentofte Hospital
Responsible party
Ida Rasmussen (Principal investigator, MD, Herlev and Gentofte Hospital) — Principal investigator
First posted
Nov 25, 2020
Start date
Mar 6, 2020
Primary completion
Sep 6, 2022 (estimated)
Completion
Sep 6, 2022 (estimated)
Last update
Nov 25, 2020

Study contacts

Anne Kirstine H Moeller, MD, PhD
Contact
anne.kirstine.hundahl.moeller@regionh.dk
+4538681083
Jesper A Palshof, MD, PhD
Contact
jesper.andreas.palshof@regionh.dk
+4538686161
Ida Marie L Rasmussen, MD
principal investigator · Department of Oncology, Herlev and Gentofte Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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