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Gemcitabine and Nab-Paclitaxel vs Gemcitabine, Nab-Paclitaxel, Durvalumab and Tremelimumab as 1st Line Therapy in Metastatic Pancreatic Adenocarcinoma
Phase 2 trial testing Gemcitabine in Pancreatic Adenocarcinoma in 180 participants. Completed in 14 March 2025.
| Lead sponsor | Canadian Cancer Trials Group |
|---|---|
| Phase | Phase 2 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 180 |
| Start date | 7 November 2016 |
| Primary completion | 3 August 2020 |
| Estimated completion | 14 March 2025 |
| Sites | 27 locations across Canada |
Canadian Cancer Trials Group — full company profile →
18 and older, any sex, with Pancreatic Adenocarcinoma. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Time from randomization to death from any cause with patients who were alive at the time of the final analysis or who became lost to follow-up censored at their last date known to be alive.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine Plus Nab-Paclitaxel | 8.8 | 7.2 – 11.2 |
| Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab | 9.8 | 8.3 – 12.2 |
Defined as the time from randomization to the first objective documentation of disease progression, defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions, or death due to any cause with patients who had not progressed or died at the time of final analysis censored on the date of the last tumour assessment.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine Plus Nab-Paclitaxel | 5.4 | 3.6 – 6.6 |
| Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab | 5.5 | 3.8 – 5.7 |
Defined as percentage of participants with objective response over all participants randomized. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Objective Response (OR) = CR + PR.
| Group | Value | 95% CI |
|---|---|---|
| Gemcitabine Plus Nab-Paclitaxel | 14 | |
| Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab | 36 | |
| Gemcitabine Plus Nab-Paclitaxel | 47 | |
| Gemcitabine + Nab-Paclitaxel + Durvalumab + Tremelimumab | 83 |
Time frame: 35 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Gemcitabine Plus Nab-Pacli… | Gemcitabine + Nab-Paclitax… |
|---|---|---|---|
| Fever | General disorders | — | — |
| Sepsis | Infections and infestations | — | — |
| Biliary tract infection | Infections and infestations | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Other immune system disorders | Immune system disorders | — | — |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | — | — |
| Febrile neutropenia | Blood and lymphatic system disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Bile duct stenosis | Hepatobiliary disorders | — | — |
| Colitis | Gastrointestinal disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Fatigue | General disorders | — | — |
| Lung infection | Infections and infestations | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Hypotension | Vascular disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Edema limbs | General disorders | — | — |
| Hepatic infection | Infections and infestations | — | — |
| Stroke | Nervous system disorders | — | — |
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | — | — |
| Cardiac arrest | Cardiac disorders | — | — |
| Duodenal stenosis | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Reaction | System | Gemcitabine Plus Nab-Pacli… | Gemcitabine + Nab-Paclitax… |
|---|---|---|---|
| Fatigue | General disorders | — | — |
| Abdominal pain | Gastrointestinal disorders | — | — |
| Nausea | Gastrointestinal disorders | — | — |
| Constipation | Gastrointestinal disorders | — | — |
| Diarrhea | Gastrointestinal disorders | — | — |
| Anorexia | Metabolism and nutrition disorders | — | — |
| Alopecia | Skin and subcutaneous tissue disorders | — | — |
| Back pain | Musculoskeletal and connective tissue disorders | — | — |
| Vomiting | Gastrointestinal disorders | — | — |
| Peripheral sensory neuropathy | Nervous system disorders | — | — |
| Edema limbs | General disorders | — | — |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | — | — |
| Insomnia | Psychiatric disorders | — | — |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | — | — |
| Fever | General disorders | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — |
| Dysgeusia | Nervous system disorders | — | — |
| Anxiety | Psychiatric disorders | — | — |
| Weight loss | Investigations | — | — |
| Thromboembolic event | Vascular disorders | — | — |
| Pruritus | Skin and subcutaneous tissue disorders | — | — |
| Arthralgia | Musculoskeletal and connective tissue disorders | — | — |
| Pain in extremity | Musculoskeletal and connective tissue disorders | — | — |
| Headache | Nervous system disorders | — | — |
| Dizziness | Nervous system disorders | — | — |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | — | — |
| Dyspepsia | Gastrointestinal disorders | — | — |
| Chills | General disorders | — | — |
| Non-cardiac chest pain | General disorders | — | — |
| Gastroesophageal reflux disease | Gastrointestinal disorders | — | — |
| Myalgia | Musculoskeletal and connective tissue disorders | — | — |
| Paresthesia | Nervous system disorders | — | — |
| Depression | Psychiatric disorders | — | — |
| Dry skin | Skin and subcutaneous tissue disorders | — | — |
| Skin infection | Infections and infestations | — | — |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | — | — |
| Flu like symptoms | General disorders | — | — |
| Dehydration | Metabolism and nutrition disorders | — | — |
| Rash acneiform | Skin and subcutaneous tissue disorders | — | — |
| Bloating | Gastrointestinal disorders | — | — |
Most-reported serious reactions: Fever, Sepsis, Biliary tract infection, Dyspnea, Other immune system disorders, Pneumonitis, Febrile neutropenia, Abdominal pain.
Data from ClinicalTrials.gov NCT02879318 adverse events section.
The standard or usual treatment for this disease consists of two chemotherapy drugs gemcitabine and nab-paclitaxel given together.
8 peer-reviewed publications reference this trial (live from Europe PMC):
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing