A Trial Comparing Gemcitabine With and Without IMM-101 in Advanced Pancreatic Cancer

Brief summary public domain (ClinicalTrials.gov)

To compare, in patients with advanced pancreatic cancer, the effects of IMM-101 in combination with gemcitabine to gemcitabine alone on safety and tolerability (including QoL), clinical signs and symptoms of disease, selected markers of tumour burden and immunological status, and disease outcome.

Detailed description public domain (ClinicalTrials.gov)

Patients in the IMM 101 treated group received an initial dose of IMM-101 followed by a maximum of 12 cycles of Gemcitabine (plus IMM-101); patients in the control group received Gemcitabine alone. All patients were to receive Gemcitabine once weekly for 3 consecutive weeks out of every 4 weeks. Patients in the IMM 101 treated group were to receive IMM 101 every 2 weeks for the first 3 doses, followed by a 4 week rest, then IMM-101 every 2 weeks for the next 3 doses. After this time, patients received doses every 4 weeks. Gemcitabine treatment began at least 14 days after the first dose of IMM-101 in the IMM 101 treated group. Patients who completed the Main Study and who provided informed consent were eligible to participate in a long term treatment Sub-Study. All patients received IMM-101 in the open-label, single arm, Sub-Study irrespective of whether they had been randomised to Gemcitabine or Gemcitabine plus IMM-101 in the main study.

Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)

Safety and Tolerability. [From time of Informed Consent to 30 days post last dose of study medication]. Number, participants. With Treatment Emergent Adverse Events (TEAEs): Experimental (n=74): 73; Control (n=35): 35. Withdrawn due to a TEAE: Experimental (n=74): 4; Control (n=35): 0. With TEAEs related to IMM-101: Experimental (n=74): 43; Control (n=35): 0. With Treatment Emergent Serious Adverse Events (TESAEs): Experimental (n=74): 38; Control (n=35): 10. With Treatment Emergent Serious Adverse Events (TESAEs) related to IMM-101: Experimental (n=74): 7; Control (n=35): 0.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Survival [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (or longer in the case of patients who entered the long term treatment sub-study, up to 5 years).]. Median, Months (95% Confidence Interval). Overall Survival: Experimental (n=75): 6.7 (5.4 to 7.5); Control (n=35): 5.6 (3.2 to 7.2). Progression Free Survival: Experimental (n=75): 4.1 (3.3 to 4.8); Control (n=35): 2.4 (2.1 to 4.0).

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Response Rate (ORR). [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (or longer in the case of patients who entered the long term treatment sub-study).]. Number, participants. Complete Response: Experimental (n=75): 0; Control (n=35): 0. Partial Response: Experimental (n=75): 8; Control (n=35): 1.

Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)

Overall Survival in Metastatic Patients Only [From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 1 year (or longer in the case of patients who entered the long term treatment sub-study, up to 5 years).]. Median, Months (95% Confidence Interval). Experimental (n=64): 7.0 (5.5 to 9.0); Control (n=28): 4.4 (2.8 to 6.5). Analysis, Experimental vs Control: Cox Proportional Hazard 0.54 (95% CI 0.33 to 0.87); p=0.011; Log Rank; other.