Pembrolizumab (KEYTRUDA ) for Cancer

National Institutes of Health Clinical Center, Bethesda, MD
Cancer+7 More ConditionsPembrolizumab (KEYTRUDA ) - Drug
Eligibility
18 - 72
All Sexes
What conditions do you have?
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Study Summary

This trial is testing whether gene transfer therapy can shrink tumors in people with metastatic cancer.

Eligible Conditions
  • Gastrointestinal/Genitourinary Cancer
  • Endocrine Tumors
  • Non-Small Cell Lung Cancer
  • Gastrointestinal/Genitourinary Cancers
  • Breast Cancer
  • Multiple Myeloma
  • Neuroendocrine Tumors
  • Ovarian Cancer

Treatment Effectiveness

Study Objectives

1 Primary · 1 Secondary · Reporting Duration: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per PI discretion

Year 2
Response rate
Week 6
Safety and tolerance

Trial Safety

Phase-Based Safety

2 of 3
This is further along than 68% of similar trials

Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 20 Other Conditions
This treatment demonstrated efficacy for 20 other conditions.

Trial Design

2 Treatment Groups

1/iTCR
1 of 2
2/iTCR + Pembro
1 of 2

Experimental Treatment

270 Total Participants · 2 Treatment Groups

Primary Treatment: Pembrolizumab (KEYTRUDA ) · No Placebo Group · Phase 2

1/iTCRExperimental Group · 4 Interventions: Aldesleukin, Individual Patient TCR-Transduced PBL, Fludarabine, Cyclophosphamide · Intervention Types: Drug, Biological, Drug, Drug
2/iTCR + PembroExperimental Group · 5 Interventions: Aldesleukin, Individual Patient TCR-Transduced PBL, Fludarabine, Cyclophosphamide, Pembrolizumab (KEYTRUDA ) · Intervention Types: Drug, Biological, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aldesleukin
FDA approved
Fludarabine
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 6 and 12 weeks after cell infusion, then every 3 months x3, then every 6 months x 2 years, then per pi discretion

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor
13,279 Previous Clinical Trials
41,234,588 Total Patients Enrolled
Steven A Rosenberg, M.D.Principal InvestigatorNational Cancer Institute (NCI)
36 Previous Clinical Trials
17,611 Total Patients Enrolled

Eligibility Criteria

Age 18 - 72 · All Participants · 2 Total Inclusion Criteria

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References

Frequently Asked Questions

Has the FDA accorded its blessing to Pembrolizumab (KEYTRUDA)?

"Our experts at Power rated Pembrolizumab's safety a 2, as the available data suggests its security but has yet to validate efficacy." - Anonymous Online Contributor

Unverified Answer

Are there any prior studies that have utilized Pembrolizumab (KEYTRUDA )?

"Presently, Pembrolizumab (KEYTRUDA ) has 1838 clinical trials underway with 283 of them being in the advanced Phase 3. These studies are largely based in Philadelphia, Pennsylvania yet can be found at 63644 different sites across the globe." - Anonymous Online Contributor

Unverified Answer

How many participants are currently being evaluated in this research investigation?

"That is correct. According to information available at clinicaltrials.gov, this experiment commenced recruitment on September 6th 2018 and was last modified on October 19th 2022. At present, it requires the participation of 270 patients from a single location." - Anonymous Online Contributor

Unverified Answer

Could I be included among the participants of this research?

"The prerequisites for this medical trial necessitate that participants suffer from neuroendocrine tumors and are aged 18 to 70. The total number of people expected to join is 270." - Anonymous Online Contributor

Unverified Answer

Does this research endeavor include individuals aged 75 and older?

"This medical trial can accept participants between 18 and 70 years of age, in accordance with the inclusion criteria." - Anonymous Online Contributor

Unverified Answer

Are there any available slots for participating in this research study?

"Confirmed. The clinical trial is indeed seeking participants for enrollment as indicated on the data hosted on clinicaltrials.gov; this study was first introduced on September 6th 2018 and underwent its most recent edit October 19th 2022. 270 patients will be recruited from a single facility." - Anonymous Online Contributor

Unverified Answer

To what maladies is Pembrolizumab (KEYTRUDA) typically used as an efficacious remedy?

"Physicians often administer pembrolizumab (KEYTRUDA) to patients with non-Hodgkins lymphoma. This medication has also been known to successfully treat malignant melanoma of the skin, recurrent cervical cancer, and leukemia." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.