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Monoclonal Antibodies

Anti-CD38 + KRAS Vaccine + Anti-PD-1 for Pancreatic & Lung Cancer (DARANIVOVAX Trial)

Phase 2
Recruiting
Led By Samir Khleif, MD
Research Sponsored by Georgetown University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease as defined by irRECIST criteria (Tumor lesions in a previously irradiated area are not considered measurable disease; Disease that is measurable by physical examination only is not eligible)
Age ≥18 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 8 weeks, approximately 2 years
Awards & highlights

DARANIVOVAX Trial Summary

This trial tests a combination of drugs to see if it can help stop or control advanced NSCLC/PDAC and how well participants' bodies handle it.

Who is the study for?
This trial is for adults over 18 with advanced non-small cell lung cancer or pancreatic ductal adenocarcinoma that's worsened despite treatment. Participants must have specific KRAS mutations, acceptable organ function, and no other recent cancers or severe illnesses. They can't be pregnant/nursing and must agree to use contraception.Check my eligibility
What is being tested?
The trial tests daratumumab (anti-CD38 antibody) combined with a KRAS vaccine and nivolumab (anti-PD-1 antibody). It aims to see how well this mix controls cancer, its safety profile, and if it extends life expectancy. Patients will undergo regular monitoring through tests and procedures.See study design
What are the potential side effects?
Potential side effects include immune system reactions causing inflammation in organs, infusion-related reactions like fever or chills, fatigue, blood disorders such as low counts of different types of cells which could increase infection risk, liver issues indicated by abnormal blood tests.

DARANIVOVAX Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My cancer can be measured by scans, not just a physical exam.
Select...
I am 18 years old or older.
Select...
I can take care of myself and perform daily activities.

DARANIVOVAX Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 8 weeks, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 8 weeks, approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Objective Response Rate (ORR) (Efficacy)
Secondary outcome measures
Clinical Benefit Rate (CBR)
Duration of Response (DOR)
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
+2 more

DARANIVOVAX Trial Design

2Treatment groups
Experimental Treatment
Group I: Refractory Non-Small Cell Lung CancerExperimental Treatment3 Interventions
Group II: Pancreatic Ductal AdenocarcinomaExperimental Treatment3 Interventions
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Daratumumab
2014
Completed Phase 3
~1990
Nivolumab
2014
Completed Phase 3
~4750

Find a Location

Who is running the clinical trial?

Targovax ASAIndustry Sponsor
5 Previous Clinical Trials
149 Total Patients Enrolled
Bristol-Myers SquibbIndustry Sponsor
2,641 Previous Clinical Trials
4,130,010 Total Patients Enrolled
Janssen, LPIndustry Sponsor
160 Previous Clinical Trials
307,936 Total Patients Enrolled

Frequently Asked Questions

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

Are there any vacancies left for participants in this experiment?

"The records on clinicaltrials.gov suggest this medical trial is no longer recruiting participants; the study was first posted on October 1st 2023 and last amended on September 1st of the same year. However, there are an ample 2717 alternative trials that require volunteer subjects."

Answered by AI

Has the FDA authorized Pancreatic Ductal Adenocarcinoma as a therapeutic protocol?

"With regards to Pancreatic Ductal Adenocarcinoma, the safety data available warrants a score of 2. This is because this Phase 2 trial has yielded evidence for its security but not yet demonstrated any efficacy."

Answered by AI

Who else is applying?

What site did they apply to?
Georgetown Lombardi Comprehensive Cancer Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer
2024. "Anti-CD38 Antibody With KRAS Vaccine and Anti-PD-1 Antibody in Subjects With Pancreatic Ductal Adenocarcinoma and Refractory Non-Small Cell Lung Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06015724.
~36 spots leftby Jan 2025
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