NCT02990416 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

Ahmadzadeh M, Johnson LA, Heemskerk B, Wunderlich JR, Dudley ME, White DE, Rosenberg SA
Tumor antigen-specific CD8 T cells infiltrating the tumor express high levels of PD-1 and are functionally impaired. Blood. 2009 Aug 20;114(8):1537-44. doi: 10.1182/blood-2008-12-195792.
Blake SJ, Ching AL, Kenna TJ, Galea R, Large J, Yagita H, Steptoe RJ
Blockade of PD-1/PD-L1 promotes adoptive T-cell immunotherapy in a tolerogenic environment. PLoS One. 2015 Mar 5;10(3):e0119483. doi: 10.1371/journal.pone.0119483.
Frankel AE, Woo JH, Ahn C, Foss FM, Duvic M, Neville PH, Neville DM
Resimmune, an anti-CD3e recombinant immunotoxin, induces durable remissions in patients with cutaneous T-cell lymphoma. Haematologica. 2015 Jun;100(6):794-800. doi: 10.3324/haematol.2015
Schumacher TN, Schreiber RD
Neoantigens in cancer immunotherapy. Science. 2015 Apr 3;348(6230):69-74. doi: 10.1126/science.aaa4971. Review.

Phase I/II Trial of the A-dmDT390-bisFv(UCHT1) Fusion Protein in Combination With Ionizing Radiation and Pembrolizumab for the Treatment of Stage IV Melanoma

Details for clinical trial NCT02990416

Clinical trial NCT02990416 - References