18 and older, any sex, with Metastatic Pancreatic Ductal Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Objective Response Rate (ORR) in All Patients Using Investigator Assessments According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)Primary· From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
ORR was defined as the percentage of patients with at least one visit response of confirmed complete response (CR) or partial response (PR). CR was defined as disappearance of all target lesions (TLs) since baseline. Any pathological lymph nodes selected as TLs must have had reduction in short axis to \<10 millimeters (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, taking as reference the baseline sum of diameters. A confirmed response meant that a response of CR/PR was recorded at 1 visit and confirmed by repeat imaging, preferably at the next regularly schedul
Confirmed responses only
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
3.1
0.08 – 16.22
Durvalumab (MEDI4736) Monotherapy
0
0 – 10.58
Confirmed and unconfirmed responses
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
3.1
0.08 – 16.22
Durvalumab (MEDI4736) Monotherapy
6.1
0.74 – 20.23
Progression-free Survival (PFS) Using Investigator Assessments According to RECIST 1.1Secondary· From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. Results are reported as median time from randomisation to PFS, calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1.5
1.2 – 1.5
Durvalumab (MEDI4736) Monotherapy
1.5
1.3 – 1.5
PFS Rate at 3 Months and at 6 MonthsSecondary· From date of first infusion until confirmed disease progression or death (up to 3 months and 6 months)
PFS was defined as the time from the date of randomisation until the date of objective disease progression or death (by any cause in the absence of progression) regardless of whether the patient had withdrawn from randomised therapy or had received another anti-cancer therapy prior to progression. PFS rates were calculated using Kaplan-Meier estimates of the cumulative probability of PFS. The PFS rate at 3 months and 6 months was equivalent to the percentage of patients with PFS after 3 months and 6 months, respectively.
PFS rate at 3 months
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
9.4
2.4 – 22.3
Durvalumab (MEDI4736) Monotherapy
10.9
3.0 – 24.7
PFS rate at 6 months
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
9.4
2.4 – 22.3
Durvalumab (MEDI4736) Monotherapy
3.6
0.3 – 15.4
Overall Survival (OS)Secondary· From date of first infusion until death (up to approximately 18 months for the data analysis cut-off)
OS was defined as the time from the date of randomisation until death due to any cause. Results are reported as median OS, calculated using the Kaplan-Meier technique.
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
3.1
2.2 – 6.1
Durvalumab (MEDI4736) Monotherapy
3.6
2.7 – 6.1
Survival Status, Presented as OS Rate, at 6 Months and at 12 MonthsSecondary· From date of first infusion until death (up to 6 months and 12 months)
OS was defined as the time from the date of randomisation until death due to any cause. OS rates were calculated using Kaplan-Meier estimates of the cumulative probability of survival at each indicated time period. The OS rate at 6 months and 12 months was equivalent to the percentage of patients with OS after 6 months and 12 months, respectively.
Survival rate at 6 months
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
36.2
20.0 – 52.7
Durvalumab (MEDI4736) Monotherapy
34.9
19.2 – 51.1
Survival rate at 12 months
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
8.8
1.8 – 22.8
Durvalumab (MEDI4736) Monotherapy
6.3
1.1 – 18.4
Best Objective Response (BoR) Using Investigator Assessments According to RECIST 1.1Secondary· From date of first infusion until confirmed disease progression or death (up to approximately 18 months for the data analysis cut-off)
BoR was calculated based on the overall visit responses from each RECIST assessment. It was the best response a patient had following date of first dosing but prior to starting any subsequent cancer therapy and prior to RECIST progression or last evaluable assessment in absence of RECIST progression. Categorisation of BoR was based on RECIST using the following response categories: CR and PR for status of 'Response'; Stable Disease (SD) ≥6 weeks, Progressive Disease (PD) and Not Evaluable (NE) for status of 'Non-response'. SD was defined as neither sufficient shrinkage to qualify for PR nor su
Response: Total
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1
Durvalumab (MEDI4736) Monotherapy
0
Response: CR
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
0
Response: PR
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1
Durvalumab (MEDI4736) Monotherapy
0
Non-response: Total
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
31
Durvalumab (MEDI4736) Monotherapy
33
Non-response: Stable disease ≥6 weeks
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
5
Durvalumab (MEDI4736) Monotherapy
7
Non-response: Progression of disease
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
26
Durvalumab (MEDI4736) Monotherapy
25
Non-response: Not evaluable
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
1
Disease Control Rate (DCR) Using Investigator Assessments According to RECIST 1.1Secondary· From date of first infusion until confirmed disease progression or death (up to 3 months, 6 months and 12 months)
DCR at 3 months was defined as the percentage of patients who have a BoR of CR or PR in the first 3 months or who have demonstrated SD for a minimum interval of 13 weeks following the start of treatment. DCR at 6 months was defined as the percentage of patients who have a BoR of CR or PR in the first 6 months or who have demonstrated SD for a minimum interval of 26 weeks following the start of treatment. DCR at 12 months was defined as the percentage of patients who have a BoR of CR or PR in the first 12 months or who have demonstrated SD for a minimum interval of 52 weeks following the start
At 3 months
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
9.4
1.98 – 25.02
Durvalumab (MEDI4736) Monotherapy
6.1
0.74 – 20.23
At 6 months
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
6.3
0.77 – 20.81
Durvalumab (MEDI4736) Monotherapy
0
0.00 – 10.58
At 12 months
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
3.1
0.08 – 16.22
Durvalumab (MEDI4736) Monotherapy
0
0.00 – 10.58
Pharmacokinetics (PK) of Durvalumab (MEDI4736)Secondary· Blood samples were collected pre-dose on Day 1 (Week 0), Week 4, Week 12 and Week 24, post-dose on Day 1, Week 12 and Week 24, and additionally at 3 months after the last dose (follow-up).
To evaluate PK, blood samples were collected pre- and post-dose and durvalumab (MEDI4736) concentrations in serum were determined. On Day 1 of Cycles 1, 4 and 7 (Weeks 0, 12 and 24), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of durvalumab and within 10 minutes of end of infusion of tremelimumab \[for patients receiving durvalumab plus tremelimumab\]). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3
Cycle 1, Day 1, pre-infusion (Day 1)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
217.338
± 345.4913
Cycle 1, Day 1, post-infusion (Day 1)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
566.078
± 151.4199
Durvalumab (MEDI4736) Monotherapy
562.218
± 152.3811
Cycle 2, Day 1, pre-infusion (Day 29)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
100.417
± 39.7229
Durvalumab (MEDI4736) Monotherapy
98.668
± 36.5072
Cycle 4, Day 1, pre-infusion (Day 85)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
236.205
± 98.8964
Durvalumab (MEDI4736) Monotherapy
228.450
± 36.8395
Cycle 4, Day 1, post-infusion (Day 85)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
825.818
± 322.8247
Durvalumab (MEDI4736) Monotherapy
760.456
± 100.6974
Cycle 7, Day 1, pre-infusion (Day 169)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
166.736
± 47.3872
Durvalumab (MEDI4736) Monotherapy
152.706
± NA
Cycle 7, Day 1, post-infusion (Day169)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
918.270
± 98.4286
Durvalumab (MEDI4736) Monotherapy
825.578
± NA
3-month follow-up
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
38.456
± NA
Durvalumab (MEDI4736) Monotherapy
19.684
± 20.2664
PK of TremelimumabSecondary· Blood samples were collected pre-dose on Day 1 (Week 0), Week 4 and Week 12, post-dose on Day 1 and Week 12, and additionally at 3 months after the last dose (follow-up).
To evaluate PK, blood samples were collected pre- and post-dose and tremelimumab concentrations in serum were determined. On Day 1 of Cycles 1 and 4 (Weeks 0 and 12), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) and post-dose at the end of infusion (within 10 minutes of end of infusion of tremelimumab). On Day 1 of Cycle 2 (Week 4), PK samples were collected pre-dose (within 60 minutes prior to treatment with any IP) only. The 3-month follow-up sample for tremelimumab was relative to the respective last dose. Results are reported as mean pre- or post-do
Cycle 1, Day 1, pre-infusion (Day 1)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
13.114
± 11.7182
Cycle 1, Day 1, post-infusion (Day 1)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
24.477
± 6.3516
Cycle 2, Day 1, pre-infusion (Day 29)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
4.880
± 2.2623
Cycle 4, Day 1, pre-infusion (Day 85)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
8.753
± 4.9962
Cycle 4, Day 1, post-infusion (Day 85)
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
21.150
± 5.8997
Presence of Antidrug Antibodies (ADAs) for Durvalumab (MEDI4736)Secondary· Immunogenicity samples were collected on Day 1 (Week 0), Week 4, Week 12 and Week 24, and additionally at 3 months and 6 months after the last dose (follow-up).
ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positi
ADA prevalence
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1
Durvalumab (MEDI4736) Monotherapy
5
ADA incidence
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
3
ADA pos post-baseline and pos at baseline
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
0
ADA pos post-baseline and not detected at baseline
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
3
ADA not detected post-baseline and pos at baseline
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1
Durvalumab (MEDI4736) Monotherapy
2
Treatment-boosted ADA
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
0
Persistent positive
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
3
Transient positive
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Durvalumab (MEDI4736) Monotherapy
0
Presence of ADAs for TremelimumabSecondary· Immunogenicity samples were collected on Day 1 (Week 0), Week 4 and Week 12, and additionally at 3 months and 6 months after the last dose (follow-up).
ADA prevalence was the proportion of the ADA evaluable set who had an ADA positive result at any point in time, baseline or post-baseline. ADA incidence (treatment-emergent ADA) was the sum of both treatment-induced (post-baseline ADA positive only) and treatment-boosted ADA positive patients as a proportion of the evaluable patient population. Treatment-boosted ADA was defined as baseline positive ADA titre boosted to a 4-fold or higher level following IP administration. Persistently positive was defined as positive at ≥2 post-baseline assessments (with ≥16 weeks between first and last positi
ADA prevalence
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
2
ADA incidence
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
ADA pos post-baseline and pos at baseline
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1
ADA pos post-baseline and not detected at baseline
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
ADA not detected post-baseline and pos at baseline
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1
Treatment-boosted ADA
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Persistent positive
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
0
Transient positive
Group
Value
95% CI
Durvalumab (MEDI4736) Plus Tremelimumab
1
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse event (TEAE) data is reported for the treatment period (up to 12 months) + follow-up (up to 90 days). Overall timeframe: up to approximately 15 months..
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Durvalumab (MEDI4736) Plus Tremelimumab
Serious: 11/32 (34%)
Deaths: 19/32
Durvalumab (MEDI4736) Monotherapy
Serious: 9/32 (28%)
Deaths: 16/32
Serious adverse events (25 terms)
Reaction
System
Durvalumab (MEDI4736) Plus…
Durvalumab (MEDI4736) Mono…
Diarrhoea
Gastrointestinal disorders
—
—
Ascites
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Cholangitis
Hepatobiliary disorders
—
—
Acute kidney injury
Renal and urinary disorders
—
—
Abdominal distension
Gastrointestinal disorders
—
—
Gastrointestinal haemorrhage
Gastrointestinal disorders
—
—
Haematemesis
Gastrointestinal disorders
—
—
Haematochezia
Gastrointestinal disorders
—
—
Intestinal obstruction
Gastrointestinal disorders
—
—
Large intestine perforation
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Asthenia
General disorders
—
—
Fatigue
General disorders
—
—
Autoimmune hepatitis
Hepatobiliary disorders
—
—
Bacteraemia
Infections and infestations
—
—
Enterococcal sepsis
Infections and infestations
—
—
Infection
Infections and infestations
—
—
Sepsis
Infections and infestations
—
—
Muscular weakness
Musculoskeletal and connective tissue disorders
—
—
Myositis
Musculoskeletal and connective tissue disorders
—
—
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
—
—
Endometrial cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
—
—
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
—
—
Embolism
Vascular disorders
—
—
Other adverse events (40 terms — click to expand)
Reaction
System
Durvalumab (MEDI4736) Plus…
Durvalumab (MEDI4736) Mono…
Fatigue
General disorders
—
—
Decreased appetite
Metabolism and nutrition disorders
—
—
Constipation
Gastrointestinal disorders
—
—
Dyspepsia
Gastrointestinal disorders
—
—
Pyrexia
General disorders
—
—
Diarrhoea
Gastrointestinal disorders
—
—
Nausea
Gastrointestinal disorders
—
—
Vomiting
Gastrointestinal disorders
—
—
Hypothyroidism
Endocrine disorders
—
—
Asthenia
General disorders
—
—
Dyspnoea
Respiratory, thoracic and mediastinal disorders
—
—
Pruritus
Skin and subcutaneous tissue disorders
—
—
Abdominal pain
Gastrointestinal disorders
—
—
Ascites
Gastrointestinal disorders
—
—
Feeling cold
General disorders
—
—
Oedema peripheral
General disorders
—
—
Hypophagia
Metabolism and nutrition disorders
—
—
Cancer pain
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
A Phase II Open-Label, Multi-Center Study of MEDI4736 Evaluated as Single Agent or in Combination with Tremelimumab in Patients with Metastatic Pancreatic Ductal Adenocarcinoma.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT02527434 — Study of Tremelimumab in Patients With Advanced Solid Tumors
· Phase 2
· completed
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 2 August 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02558894.