Phase 2
Completed N=97
A Phase 1/2, Open-label Study to Evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination With Durvalumab Versus Nivolumab Monotherapy in Participants With Select Advanced Malignancies
Select Advanced Malignancies · Kidney Cancer · Renal Clear Cell Carcinoma
Source: ClinicalTrials.gov NCT02118337 ↗
Enrolled (actual)
97
Serious AEs
50.5%
Results posted
Jun 2021
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase — 4; 5; 3; 3 Participants
Summary
To evaluate the Safety and Antitumor Activity of MEDI0680 (AMP-514) in Combination with Durvalumab versus Nivolumab Monotherapy in Participants with Select Advanced Malignancies.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in Dose-escalation Phase |
4; 5; 3; 3; 9; 6 | — |
| PRIMARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-escalation Phase |
0; 0; 1; 1; 3; 0 | — |
| PRIMARY Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAES in Dose-escalation Phase |
0; 0; 0; 0; 1; 0 | — |
| PRIMARY Number of Participants With Abnormal Electrocardiograms (ECGs) Reported as TEAEs in Dose-escalation Phase |
1; 0; 0; 0; 0; 0 | — |
| PRIMARY Objective Response Rate (ORR) Based on Investigator-assessed Response Using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1) in Dose-expansion Phase |
0; 16.7; 23.8 | 0.5494 |
| SECONDARY Best Overall Response (BOR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase |
0; 2; 0; 0; 5; 5 | — |
| SECONDARY Disease Control Rate (DCR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase |
75.0; 57.1; 61.9; 50.0; 38.1; 38.1 | — |
| SECONDARY Time to Response (TTR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase |
1.8; 1.8 | — |
| SECONDARY Duration of Response (DoR) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase |
NA; NA | — |
| SECONDARY Progression Free Survival (PFS) Based on Investigator-assessed RECIST v1.1 in Dose-expansion Phase |
5.5; 3.6; 3.6 | — |
| SECONDARY Overall Survival in Dose-expansion Phase |
19.9; NA; NA | — |
| SECONDARY BOR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase |
0; 0; 0; 0; 1; 0 | — |
| SECONDARY ORR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase |
50.0; 0; 33.3; 0; 44.4; 66.7 | — |
| SECONDARY DCR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase |
75.0; 20.0; 33.3; 33.3; 66.7; 83.3 | — |
| SECONDARY TTR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase |
2.6; 3.4; 3.5; 3.2 | — |
| SECONDARY DoR Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase |
16.8; NA; 7.4; NA | — |
| SECONDARY PFS Based on Investigator-assessed Modified RECIST v1.1 in Dose-escalation Phase |
20.2; 1.7; 1.6; 1.8; 7.0; 23.4 | — |
| SECONDARY OS in Dose-escalation Phase |
16.3; NA; 14.7; 7.9; 12.8; NA | — |
| SECONDARY Number of Participants With TEAEs and TESAEs in Dose-expansion Phase |
4; 42; 20; 3; 22; 13 | — |
| SECONDARY Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in Dose-expansion Phase |
1; 6; 5; 0; 1; 0 | — |
| SECONDARY Number of Participants With Abnormal Vital Signs and Physical Examinations Reported as TEAEs in Dose-expansion Phase |
0; 2; 1; 0; 1; 0 | — |
| SECONDARY Number of Participants With Abnormal ECGs Reported as TEAEs in Dose-expansion Phase |
1; 1; 0; 0; 1; 0 | — |
| SECONDARY Antitumor Activity of MEDI0680 and Durvalumab Versus Nivolumab Monotherapy in Immunotherapy-Naïve Participants With Advanced or Metastatic Clear-cell Renal Cell Carcinoma (ccRCC) Based on Blinded Independent Central Review (BICR) in Dose-expansion Phase |
— | — |
| SECONDARY Percent Change From Baseline in Tumor Size in Dose-escalation Phase (Based on Investigator-assessed Modified RECIST v1.1) and Dose-expansion Phase (Based on Investigator-assessed RECIST v1.1) |
— | — |
| SECONDARY Serum Concentration of MEDI0680 in Dose-escalation and Dose-expansion Phases |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Serum Concentration of Durvalumab in Dose-escalation and Dose-expansion Phases |
NA; NA; NA; NA; NA; NA | — |
| SECONDARY Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI0680 in Dose-escalation and Dose-expansion Phases |
2; 0; 2; 0; 0; 0 | — |
| SECONDARY Number of Participants With Positive ADA to Durvalumab in Dose-escalation and Dose-expansion Phases |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY ORR for Participants With Programmed Cell Death Ligand 1 (PD-L1) Status Positive and Negative in Dose-expansion Phase |
0; 40.0; 37.5; 0; 13.5; 15.4 | — |
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older
- Eastern Cooperative Oncology Group performance status of 0-1
- Adequate organ function
- At least 1 prior line of therapy
Exclusion Criteria
- Concurrent enrollment in another clinical study, unless in follow-up period or it is an observational study
- Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment
- Prior treatment with immunotherapy
Data sourced from ClinicalTrials.gov (NCT02118337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.