A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
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ClinicalTrials.gov Identifier: NCT02671435 |
Recruitment Status :
Recruiting
First Posted : February 2, 2016
Last Update Posted : December 2, 2019
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Condition or disease | Intervention/treatment | Phase |
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Advanced Solid Tumors | Combination Product: Intervention | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 501 participants |
Allocation: | Non-Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select Advanced Solid Tumors |
Actual Study Start Date : | February 22, 2016 |
Estimated Primary Completion Date : | December 31, 2021 |
Estimated Study Completion Date : | December 31, 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Part 1 -Dose escalation with 5 dose escalation cohorts
Durvalumab and monalizumab
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Combination Product: Intervention
Biological: Durvalumab Biological: Monalizumab Biological: Cetuximab |
Experimental: Part 2 - Dose expansion with 4 dose expansion cohorts
Durvalumab with monalizumab
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Combination Product: Intervention
Biological: Durvalumab Biological: Monalizumab Biological: Cetuximab |
Experimental: Part 3 -Dose Exploration with 10 dose exploration cohorts.
Durvalumab and monalizumab and standard of standard of care systemic therapy with or without a biologic agent and monalizumab in combination with biologic agent in CRC.
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Combination Product: Intervention
Biological: Durvalumab Biological: Monalizumab Biological: Cetuximab |
- Occurrence of Drug Limited Toxicities (DLTs) [ Time Frame: From Time of First dose through DLT Screening period ]To assess by the occurrence of Drug Limited Toxicities (DLTs)
- Number of patients with changes in vital signs from baseline [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]To assess safety of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent or monalizumab + with biological agent
- Occurrence of adverse events (AEs) [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]To assess by the occurrence of adverse events (AEs)
- Number of patients with changes in electrocariogram (ECG) from baseline [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]To assess safety of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Occurrence of serious adverse events (SAEs) [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]To assess by the occurrence of serious adverse events (SAEs)
- Number of patients with changes in laboratory parameters from baseline [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]To assess safety of monalizumab +durva, or monalizumab +durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Objective Response Rate (ORR) [ Time Frame: From time of first dose of study medication through 5 years ]To assess anti-tumor activity of monalizumab + durva without biological agent, or monalizumab + with biological agent
- Expression of pre-treatment protein within the tumor microenvironment [ Time Frame: From time of screening through 90 days (+/- 7 days) after the last dose of study medication ]To assess biomarker predicting activity of monalizumab+durva in combo with standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Number of subjects who develop anti-drug antibodies [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]To assess the immunogenicity of mona+durva with or without standard of care systemic therapy or biological agent, or monalizumab + with biological agent
- Durva, monalizumab, biologic agent serum peak concentration (cMax) concentration for Pharmacokinetics [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Durva and monalizumab serum area under the concentration-time curve (AUC) concentration for Pharmacokinetics [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, monalizumab + with biological agent
- Durva and monalizumab serum clearance (CL) concentration for Pharmacokinetics [ Time Frame: From time of first dose through 90 days (+/- 7 days) after the last dose of study medication ]To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Durva and monalizumab serum terminal elimination half-life (t1/2) concentration for Pharmacokinetics [ Time Frame: From first dose through 90 days (+/- 7 days) after the last dose of study medication ]To assess the pharmacokinetics of Durvalumab and monalizumab or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Objective Response Rate (ORR) [ Time Frame: From time of first dose of study medication through 5 years ]To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Progression Free Survival (PFS) [ Time Frame: From time of first dose of study medication through 5 years ]To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Disease Control Rate (DC) [ Time Frame: From time of first dose of study medication through 5 years ]To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Overall Survival (OS) [ Time Frame: From time of first dose of study medication through 5 years ]To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent
- Duration of Response (DoR) [ Time Frame: From time of first dose of study medication through 5 years ]To assess anti-tumor activity of monalizumab +durva, or monalizumab+durva +standard of care systemic therapy with or without biological agent, or monalizumab + with biological agent

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Subjects must have histologic documentation of advanced recurrent or metastatic cancer.
- Subjects must be at the recurrent/metastatic setting, with selected advanced solid tumors.
- Subjects must have at least one lesion that is measurable by RECIST v1.1
- Part 3, Dose exploration, CRC subjects can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting.
Exclusion Criteria
- Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor.
- Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed
- Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment
- Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02671435
Contact: AstraZeneca Clinical Study Information Center | 1-877-240-9479 | information.center@astrazeneca.com |

Responsible Party: | MedImmune LLC |
ClinicalTrials.gov Identifier: | NCT02671435 History of Changes |
Other Study ID Numbers: |
D419NC00001 D419NC00001 ( Other Grant/Funding Number: Medimmune LLC ) |
First Posted: | February 2, 2016 Key Record Dates |
Last Update Posted: | December 2, 2019 |
Last Verified: | November 2019 |
Colorectal, colon, CRC, solid tumors, check point inhibitors, immunotherapy, metastatic |
Neoplasms Durvalumab Antibodies, Monoclonal Antineoplastic Agents, Immunological |
Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs |