[No standalone website (unbranded, no questionnaire)] A Study of Subjects With Psoriatic Arthritis to Investigate the Effectiveness of Adalimumab Introduction Compared With Methotrexate Dose Escalation (CONTROL)

How to apply

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Study’s contact

Call center

1-888-669-6682

Email address

novartis.email@novartis.com

Condition

BRAF V600 Colorectal Cancer

Treatment type

Interventional

Investigational product

Spartalizumab

Phase

Phase 1

Sponsor

Novartis

ClinicalTrials.gov identifier

NCT04294160

Study number

CADPT01C12101

Understanding clinical trials

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About the study

A phase Ib, open-label platform study of select drug combinations chosen in order to characterize safety and tolerability of each treatment arm tested and to identify recommended doses and regimens for future studies.

Who can take part?

You may be eligible to participate in the study if you meet the following criteria:

Inclusion criteria

  1. Patients with advanced/metastatic BRAF V600 cancer of the colon or rectum with measurable disease as determined by RECIST v1.1
  2. Patients must have a site of disease amenable to biopsy, and be a candidate for tumor biopsy according to the treating institution's guidelines. Patients must be willing to undergo a new tumor biopsy at baseline and during therapy on study.
Exclusion criteria

  1. Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy, or in-situ cervical cancer, or other tumors that will not affect life expectancy.
  2. Current evidence/known risk of uveitis in the opinion of the investigator
  3. A history of or current evidence/risk of retinal vein occlusion (RVO) or serous retinopathy
  4. History of or current interstitial lung disease or non-infectious pneumonitis
  5. Patients with a history of diabetes requiring medical therapy that is not well-controlled on a stable regimen in the opinion of the investigator
  6. Insufficient bone marrow function prior to start of treatment
  7. Insufficient hepatic or renal function prior to start of treatment
  8. Patients who have potassium, magnesium, calcium (corrected for serum albumin), or phosphate laboratory values outside of the laboratory normal limits
  9. Patients with active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
  10. Patients with known history of testing positive for Human Immunodeficiency Virus (HIV).
  11. Clinically significant cardiac disease at screening
  12. Pregnant or lactating women

For a full list of inclusion/exclusion criteria, please visit ClinicalTrials.gov

Study locations

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How to apply

Determine if a study site for this clinical trial is near you. Contact the study to apply.

Find a Study Site