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DKY709 + PDR001 for Cancer

Phase 1
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Dose expansion part, patients must fit into one of the following groups: NSCLC with historic documentation of PD-L1 ≥ 1%. Patients must have progressive disease after having experienced at least 4 months of investigator-assessed disease stability or response on prior anti-PD-L1-containing therapy; Cutaneous Melanoma, previously treated with anit-PD-1/PD-L1 therapy. Patients should have documented progression following anti-PD-1/PD-L1 therapy; NPC, naive to anti-PD-1/PD-L1 therapy; mssCRC, naive to anti-PD-1/PD-L1 therapy; TNBC, naive to anti-PD-1/PD-L1 therapy
Patients must be ≥18 years of age at the time of informed consent form (ICF) signature
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
No Placebo-Only Group

Study Summary

This trial is testing a new cancer treatment to see if it is safe and effective.

Who is the study for?
Adults (≥18 years) with advanced cancers like NSCLC, melanoma, NPC, mssCRC, or TNBC who have progressed after standard therapy or are intolerant to it. Participants must have measurable disease and be willing to undergo tumor biopsies. Excluded are those with significant heart issues, severe allergies to study drugs' ingredients, certain abnormal lab values, symptomatic CNS metastases or recent cardiac events.Check my eligibility
What is being tested?
The trial is testing the safety and effectiveness of DKY709 alone and in combination with PDR001 for treating various advanced solid tumors. It's a phase I/Ib study that includes an initial dose escalation to find the maximum tolerated dose followed by expansion at this dose to further evaluate the treatments.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical reactions may include immune-related inflammation in organs due to PDR001 (an immunotherapy), infusion reactions from either drug administration, fatigue from treatment burden on the body's resources and potential blood abnormalities.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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For the additional part of the study, patients must have one of the following: non-small cell lung cancer with a history of PD-L1 levels of at least 1% and disease progression after at least 4 months of stable or improved condition with previous anti-PD-L1 treatment; previously treated cutaneous melanoma with documented disease progression after anti-PD-1/PD-L1 therapy; nasopharyngeal carcinoma (NPC) without prior anti-PD-1/PD-L1 therapy; microsatellite stable colorectal cancer (mssCRC) without prior anti-PD-1/PD-L1 therapy; triple-negative breast cancer (TNBC) without prior anti-PD-1/PD-L1 therapy.
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I am 18 years old or older.
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My advanced cancer has worsened after standard treatment, or I can't tolerate it, and no other standard treatments work for me.
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I have NSCLC or melanoma treated with anti-PD-1/PD-L1 therapy, or I have NPC.
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I am fully active and can carry on all my pre-disease activities without restriction.
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I am willing and able to have a biopsy of my cancer as per my hospital's rules.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of DKY709 single agent treatment or DKY709 in combination with PDR001.
Tolerability of DKY709 single agent treatment or DKY709 in combination with PDR001.
incidence of Dose Limiting Toxicities (DLTs)
Secondary outcome measures
AUC of DKY709 and PDR001
Best Overall Response (BOR)
Cmax of DKY709 and PDR001
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: DKY709 + PDR001Experimental Treatment2 Interventions
Combination therapy with DKY709 and PDR001
Group II: DKY709Experimental Treatment1 Intervention
DKY709 monotherapy
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PDR001
2016
Completed Phase 2
~2700

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,842 Previous Clinical Trials
4,193,038 Total Patients Enrolled

Media Library

DKY709 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03891953 — Phase 1
Colorectal Cancer Research Study Groups: DKY709, DKY709 + PDR001
Colorectal Cancer Clinical Trial 2023: DKY709 Highlights & Side Effects. Trial Name: NCT03891953 — Phase 1
DKY709 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03891953 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What risks, if any, are associated with PDR001?

"As PDR001 is currently in its initial clinical trial, the safety score assigned to this medication was a 1. This indicates that there are only limited data supporting both efficacy and security."

Answered by AI

Is this experiment a pioneering endeavor in its field?

"Since its inception in 2011, PDR001 has been subject to many trials. The initial study was sponsored by Novartis Pharmaceuticals and yielded 185 participants. Subsequently the drug received approval for Phase 1 in 2011 and currently there are 27 active studies occurring across 122 urban areas and 35 nations."

Answered by AI

How many participants are presently being treated with this experimental protocol?

"Affirmative. The clinicaltrials.gov website supports the fact that this medical investigation is actively recruiting volunteers - it was first announced on May 7th 2019 and most recently updated on 26th of May 2022. This trial requires 380 participants to be recruited from three sites in total."

Answered by AI

Is there any existing research exploring the effects of PDR001?

"PDR001 was initially investigated by the UCLA School of Medicine in 2011. There have been 21 concluded studies and there are currently 27 trials still ongoing, with a substantial amount of these being conducted out of Nashville, Tennessee."

Answered by AI

Are there any new participants currently being accepted for this research project?

"Affirmative. According to the information hosted on clinicaltrials.gov, this research is actively seeking volunteers since it was initially announced on May 7th 2019 and last modified on May 26th 2022. 380 participants are needed for the study at 3 distinct sites."

Answered by AI

What is the end goal of this investigation?

"This 1 month clinical trial intends to assess the tolerability of DKY709 as a single agent or in combination with PDR001. The secondary objectives include determining the best overall response and measuring the area under curve (AUC) and maximum concentration (Cmax) of both drugs being tested."

Answered by AI
~19 spots leftby May 2025