A Phase 1/2, First-In-Human, Multi-Part, Open-Label, Multiple-Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Biological, and Clinical Activity of DF6002 as a Monotherapy and in Combination With Nivolumab in Patients With Locally Advanced or Metastatic Solid Tumors, and Expansion in Selected Indications

  • STATUS
    Recruiting
  • End date
    Dec 16, 2025
  • participants needed
    473
  • sponsor
    Bristol-Myers Squibb
Updated on 22 October 2022
renal function
cancer
immunosuppressant
tyrosine
lymphoma
hodgkin's disease
immunosuppressive
monoclonal antibodies
systemic therapy
estrogen
measurable disease
carcinoma
breast cancer
anticoagulants
hepatitis
growth factor
squamous cell carcinoma
lung cancer
progesterone
BRAF
major surgery
experimental drug
metastasis
progressive disease
esophageal cancer
pembrolizumab
ROS1
RET
HER2
EGFR
carcinoma in situ
pd-l1
programmed cell death 1 ligand 1
nivolumab
cancer treatment
neuropathy
cancer chemotherapy
recurrent disease
solid tumour
alopecia
triple negative breast cancer
progesterone receptor
erbb2
estrogen receptor
autoimmune disease
squamous cell carcinoma of head and neck
braf inhibitor
asthma
anticoagulant
renal function tests
interleukin 2
growth factors
transitional cell carcinoma
platinum-based chemotherapy
advanced urothelial carcinoma
metastatic transitional cell carcinoma
metastatic urothelial carcinoma
immunomodulator
immunostimulants
cervical carcinoma
immunomodulators
advanced renal cell carcinoma
endometrial carcinoma
kidney function test
advanced melanoma
lung carcinoma
cytokine therapy
immunologic adjuvant

Summary

The purpose of this study is to evaluate the safety, tolerability, drug-levels, drug-effects and preliminary anti-tumor activity of DF6002 (BMS-986415) alone and in combination with Nivolumab in participants with advanced solid tumors.

Details
Condition Solid Tumors
Treatment Pembrolizumab, Nivolumab, DF6002
Clinical Study IdentifierNCT04423029
SponsorBristol-Myers Squibb
Last Modified on22 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Advanced/metastatic solid tumors, for which no standard therapy exists or standard therapy has failed among the following tumor types: melanoma, non-small cell lung cancer, small cell lung cancer, head and neck squamous cell, urothelial, gastric, esophageal, cervical, hepatocellular, merkel cell, cutaneous squamous cell carcinoma, renal cell, endometrial, triple-negative breast, ovarian, and prostate
ECOG performance status of 0 or 1
Clinical or radiological evidence of disease
Adequate hematological, hepatic and renal function
Anticoagulants are required for the following: Khorana Risk Score ≥ 2 or as assessed by Investigator as being at high risk for venous thromboembolism (VTE) or history of VTE ≥ 6 months from enrollment

Exclusion Criteria

Concurrent anticancer treatment (with the exception of palliative bone directed radiotherapy), immune therapy, or cytokine therapy (except for erythropoietin), major surgery (excluding prior diagnostic biopsy), concurrent systemic therapy with steroids or other immunosuppressive agents, or use of any investigational drug within 28 days before the start of study treatment
Previous malignant disease other than the current target malignancy within the last 3 years, with the exception of basal or squamous cell carcinoma of the skin, localized prostate cancer or cervical carcinoma in situ
Rapidly progressive disease
Serious cardiac illness or medical conditions
Other protocol-defined inclusion/exclusion criteria apply
Known diagnosis of antiphospholipid syndrome or clinically significant hereditary thrombophilia
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Browse trials for

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note