Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Carcinoma, Renal Cell

Urologic Neoplasms

Urogenital Neoplasms

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Renal Cell Carcinoma

Clear Cell Renal Cell Carcinoma

Antineoplastic Agents

All Drugs and Chemicals

Nivolumab

Pembrolizumab

Trastuzumab

Osimertinib

Olaparib

Palbociclib

Sunitinib

Trametinib

Dabrafenib

Crizotinib

Alectinib

Imatinib Mesylate

Erlotinib Hydrochloride

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.

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.

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.

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

Medication (A specification is listed under each arm)

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.

Patient reported outcomes measurement

Anne Kirstine H Moeller, MD, PhD

Jesper A Palshof, MD, PhD

Ida Marie L Rasmussen, MD

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.

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

A Phase II Study of an Individualized Treatment Strategy for Patients With Metastatic Non-clear Cell Renal Cell Carcinoma

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

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

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

Overall survival for the total population

Progression-free survival for the total population

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

Response duration for the total population.

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

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

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

Spots Global Cancer Trial Database for patient reported outcomes measurement