This study is NOT currently recruiting participants.
Number
000647-C
Sponsoring Institute
National Cancer Institute (NCI)
Recruitment Detail
Type: Recruitment has not started Gender: Male & Female Min Age: 18 Years Max Age: 120 Years
Referral Letter Required
Yes
Population Exclusion(s)
Neonates;Fetuses;Pregnant Women;Children
Keywords
Rollover; 15c0179
Recruitment Keyword(s)
None
Condition(s)
NSCLC; Solid Tumor
Investigational Drug(s)
Bintrafusp alfa
Investigational Device(s)
Intervention(s)
Drug: Bintrafusp alfa
Supporting Site
National Cancer Institute
Bintrafusp alfa is a new cancer drug. It aims to help a person s immune system act against cancer. It is not known if the drug works over a longer period of time. Researchers want to study the cancer response in people who are already taking the drug in a clinical trial.
Objective:
To study the safety of bintrafusp alfa for treating different types of cancer and whether it works over a longer period of time for people who are currently in clinical studies for the drug.
Eligibility:
Adults ages 18 and older with cancer who are taking part in a clinical study for bintrafusp alfa.
Design:
Participants will be screened with a medical history, skin assessment, and blood tests. They will have imaging scans to assess their tumor. For this, they will lie on a table that slides into a scanner. The scanner will take pictures of their body. They may receive a contrast dye through their veins.
Participants will receive the study drug once every 2 or 3 weeks by IV (a drip in the vein). They will receive the drug until their cancer responds well or gets worse or they have bad side effects.
Participants will be seen regularly during the study. At study visits, they may repeat some screening tests. They may have a physical exam, heart test, and/or urine test. They may answer questions about how their cancer affects their daily life and well-being.
Participants will have a follow-up visit within either 7 or 30 days after treatment ends. They will have a telephone follow-up 90 days after treatment ends, then every 12 weeks for up to 5 years.
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ELIGIBILITY CRITERIA: -Are >= 18 years of age at the time of signing the informed consent. -Are participants currently enrolled in an eligible bintrafusp alfa parent study (15-C-0179 at NIH) where the primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed and who: --Are currently on active bintrafusp alfa treatment (alone as a monotherapy or following discontinuation of other combination treatment agents) in the parent study and without treatment interruption at the time of rollover study enrollment, OR, --Experienced a confirmed CR, PR, or SD in an eligible parent study, discontinued bintrafusp alfa treatment according to the parent study protocol, and subsequently developed disease progression and are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants physicians OR, --Discontinued from bintrafusp alfa treatment in an eligible parent study due to an AE(s) that was subsequently well controlled or completely resolved after stopping therapy, provided that the parent study protocol permits reinitiation of bintrafusp alfa if a participant discontinued treatment due to toxicity and these participants are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants physicians. Participants who have had AEs requiring permanent treatment discontinuation, like certain irAEs or certain bleeding events are excluded from participation in this Rollover study. -Have completed End of treatment (EoT) assessment of a parent study -Women who are pregnant or lactating are excluded -Participants may not have received any systemic anticancer therapy/treatment since discontinuing bintrafusp alfa treatment. -Participants who have withdrawn from the parent study for any reason are excluded
-Are >= 18 years of age at the time of signing the informed consent.
-Are participants currently enrolled in an eligible bintrafusp alfa parent study (15-C-0179 at NIH) where the primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed and who:
--Are currently on active bintrafusp alfa treatment (alone as a monotherapy or following discontinuation of other combination treatment agents) in the parent study and without treatment interruption at the time of rollover study enrollment,
OR,
--Experienced a confirmed CR, PR, or SD in an eligible parent study, discontinued bintrafusp alfa treatment according to the parent study protocol, and subsequently developed disease progression and are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants physicians
--Discontinued from bintrafusp alfa treatment in an eligible parent study due to an AE(s) that was subsequently well controlled or completely resolved after stopping therapy, provided that the parent study protocol permits reinitiation of bintrafusp alfa if a participant discontinued treatment due to toxicity and these participants are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants physicians. Participants who have had AEs requiring permanent treatment discontinuation, like certain irAEs or certain bleeding events are excluded from participation in this Rollover study.
-Have completed End of treatment (EoT) assessment of a parent study
-Women who are pregnant or lactating are excluded
-Participants may not have received any systemic anticancer therapy/treatment since discontinuing bintrafusp alfa treatment.
-Participants who have withdrawn from the parent study for any reason are excluded
Principal Investigator
Referral Contact
For more information: