Hodgkin Lymphoma
Conditions
Keywords
PD1, PD-1, PDL1, PD-L1
Brief summary
This is a study of pembrolizumab (MK-3475) for participants with relapsed/refractory classical Hodgkin Lymphoma (RRcHL) who: 1) have failed to achieve a response or progressed after autologous stem cell transplant (auto-SCT) and have relapsed after treatment with or failed to respond to brentuximab vedotin (BV) post auto-SCT or 2) were unable to achieve a Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV or 3) have failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT. The primary study hypothesis is that treatment with single agent pembrolizumab will result in a clinically meaningful overall response rate.
Interventions
BIOLOGICALpembrolizumab
IV infusion
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Relapsed or refractory de novo classical Hodgkin lymphoma * Participant may have failed to achieve a response to, progressed after, or be ineligible for autologous stem cell transplant (auto-SCT) * Participant may have failed to achieve a response or progressed after treatment with brentuximab vedotin or may be brentuximab vedotin naïve * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Measurable disease * Adequate organ function
Exclusion criteria
* Diagnosis of immunosuppression or receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication * Prior monoclonal antibody within 4 weeks prior to study Day 1 or chemotherapy, targeted small molecular therapy, or radiation therapy within 2 weeks prior to study Day 1 * Prior allogeneic hematopoietic stem cell transplantation * Known clinically active central nervous system involvement * Known additional malignancy that is progressing or requires active treatment * Has a known history of Human Immunodeficiency Virus (HIV) * Has known active Hepatitis B (HBV) or Hepatitis C (HCV) * Active autoimmune disease requiring systemic treatment in past 2 years * Has a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) by BICR Based on IWG Criteria | Up to approximately 99 months | ORR is the percentage of participants who had a complete response (CR) or partial response (PR) prior to disease progression based on the International Working Group (IWG) criteria using blinded independent central review (BICR). CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. It is hypothesized that ORR will be greater than 20% in each of the 3 cohorts. |
| Percentage of Participants Experiencing at Least One Adverse Event (AE) | Up to 27 months | An adverse event (AE) is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study |
| Percentage of Participants Discontinuing Study Drug Due to AEs | Up to 24 months | An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission Rate (CRR) by BICR Based on IWG Criteria | Up to approximately 99 months | CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the IWG criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria. |
| Complete Remission Rate (CRR) by BICR Based on Lugano Criteria | Up to approximately 99 months | CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the Lugano criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria. |
| Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria | Up to approximately 99 months | CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes assessed by the investigator using IWG criteria. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria. |
| Overall Survival (OS) | Up to approximately 99 months | OS is the time from the first dose to death due to any cause. The Kaplan-Meier method was used to estimate the survival curve, separately by Cohort with missing data censored at last assessment. |
| Progression-free Survival (PFS) Assessed by the Investigator | Up to approximately 99 months | PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by the investigator based on the IWG criteria. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment. |
| Duration of Response (DOR) Based on BICR | Up to approximately 99 months | DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first based on BICR. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment. |
| Duration of Response (DOR) Assessed by the Investigator | Up to approximately 99 months | DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first assessed by the investigator based on the IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment. |
| Progression-free Survival (PFS) Based on BICR | Up to approximately 99 months | PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first based on BICR. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment. |
| Overall Response Rate (ORR) by BICR Based on Lugano Criteria | Up to approximately 99 months | ORR is the percentage of participants who had a CR or PR prior to disease progression based on the Lugano criteria using BICR. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. |
| Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria | Up to approximately 99 months | ORR is the percentage of participants who had a CR or PR prior to disease progression assessed by the investigator using IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. |
Participant flow
Recruitment details
Males and females with relapsed or refractory de novo classical Hodgkin lymphoma (RRcHL) of at least 18 years of age were enrolled in this study.
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 Participants with RRcHL who failed to achieve a response or progressed after auto-SCT and have relapsed after treatment with or failed to respond to BV post auto-SCT received pembrolizumab, 200 mg, intravenously (IV) every 3 weeks (Q3W) on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. | 69 |
| Cohort 2 Participants with RRcHL who were unable to achieve Complete Response (CR) or Partial Response (PR) to salvage chemotherapy and did not receive auto-SCT, but have relapsed after treatment with or failed to respond to BV received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle up to 35 cycles, for up to 24 months. | 81 |
| Cohort 3 Participants with RRcHL who failed to achieve a response to or progressed after auto-SCT and have not received BV post auto-SCT received pembrolizumab, 200 mg, IV Q3W on Day 1 of each 21-day cycle, up to 35 cycles for up to 24 months. These participants may or may not have received BV as part of primary treatment or salvage treatment. | 60 |
| Total | 210 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Cohort Was Closed | 17 | 21 | 14 |
| Overall Study | Death | 20 | 24 | 16 |
| Overall Study | Lost to Follow-up | 6 | 14 | 2 |
| Overall Study | Physician Decision | 2 | 4 | 0 |
| Overall Study | Protocol Violation | 0 | 0 | 1 |
| Overall Study | Site Terminated by Sponsor | 1 | 0 | 1 |
| Overall Study | Transitioned to Extension Study | 16 | 9 | 16 |
| Overall Study | Withdrawal by Subject | 7 | 9 | 11 |
Baseline characteristics
| Characteristic | Cohort 1 | Cohort 2 | Cohort 3 | Total |
|---|---|---|---|---|
| Age, Continuous | 37.0 Years STANDARD_DEVIATION 10.9 | 42.3 Years STANDARD_DEVIATION 17.4 | 36.8 Years STANDARD_DEVIATION 13.4 | 39.0 Years STANDARD_DEVIATION 14.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 5 Participants | 3 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 43 Participants | 63 Participants | 48 Participants | 154 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 19 Participants | 13 Participants | 9 Participants | 41 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 4 Participants | 1 Participants | 12 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) White | 57 Participants | 73 Participants | 55 Participants | 185 Participants |
| Sex: Female, Male Female | 33 Participants | 38 Participants | 26 Participants | 97 Participants |
| Sex: Female, Male Male | 36 Participants | 43 Participants | 34 Participants | 113 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 21 / 69 | 28 / 81 | 19 / 61 | 2 / 10 | 0 / 7 | 0 / 3 |
| other Total, other adverse events | 68 / 69 | 76 / 81 | 56 / 60 | 10 / 10 | 7 / 7 | 3 / 3 |
| serious Total, serious adverse events | 15 / 69 | 18 / 81 | 15 / 60 | 0 / 10 | 1 / 7 | 0 / 3 |
Outcome results
Primary
Overall Response Rate (ORR) by BICR Based on IWG Criteria
ORR is the percentage of participants who had a complete response (CR) or partial response (PR) prior to disease progression based on the International Working Group (IWG) criteria using blinded independent central review (BICR). CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort. It is hypothesized that ORR will be greater than 20% in each of the 3 cohorts.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Overall Response Rate (ORR) by BICR Based on IWG Criteria | 78.3 Percentage of participants |
| Cohort 2 | Overall Response Rate (ORR) by BICR Based on IWG Criteria | 64.2 Percentage of participants |
| Cohort 3 | Overall Response Rate (ORR) by BICR Based on IWG Criteria | 73.3 Percentage of participants |
Primary
Percentage of Participants Discontinuing Study Drug Due to AEs
An AE is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study
Time frame: Up to 24 months
Population: All allocated participants who received at least 1 dose of study treatment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants Discontinuing Study Drug Due to AEs | 11.6 Percentage of Participants |
| Cohort 2 | Percentage of Participants Discontinuing Study Drug Due to AEs | 6.2 Percentage of Participants |
| Cohort 3 | Percentage of Participants Discontinuing Study Drug Due to AEs | 8.3 Percentage of Participants |
Primary
Percentage of Participants Experiencing at Least One Adverse Event (AE)
An adverse event (AE) is any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study
Time frame: Up to 27 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Percentage of Participants Experiencing at Least One Adverse Event (AE) | 98.6 Percentage of Participants |
| Cohort 2 | Percentage of Participants Experiencing at Least One Adverse Event (AE) | 98.8 Percentage of Participants |
| Cohort 3 | Percentage of Participants Experiencing at Least One Adverse Event (AE) | 95.0 Percentage of Participants |
Secondary
Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria
CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes assessed by the investigator using IWG criteria. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria | 42.0 Percentage of participants |
| Cohort 2 | Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria | 32.1 Percentage of participants |
| Cohort 3 | Complete Remission Rate (CRR) Assessed by Investigator Based on IWG Criteria | 43.3 Percentage of participants |
Secondary
Complete Remission Rate (CRR) by BICR Based on IWG Criteria
CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the IWG criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Complete Remission Rate (CRR) by BICR Based on IWG Criteria | 24.6 Percentage of participants |
| Cohort 2 | Complete Remission Rate (CRR) by BICR Based on IWG Criteria | 25.9 Percentage of participants |
| Cohort 3 | Complete Remission Rate (CRR) by BICR Based on IWG Criteria | 33.3 Percentage of participants |
Secondary
Complete Remission Rate (CRR) by BICR Based on Lugano Criteria
CRR is the percentage of participants with complete remission as demonstrated by disappearance of all evidence of disease in the bone marrow, spleen, liver, and lymph nodes based on the Lugano criteria using BICR. The analysis consisted of the point estimate and 95% 2-sided exact CI, separately by Cohort using the Clopper-Pearson method. Additional analyses were based on site assessment and by central review using the Lugano (2014) criteria.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Complete Remission Rate (CRR) by BICR Based on Lugano Criteria | 34.8 Percentage of participants |
| Cohort 2 | Complete Remission Rate (CRR) by BICR Based on Lugano Criteria | 28.4 Percentage of participants |
| Cohort 3 | Complete Remission Rate (CRR) by BICR Based on Lugano Criteria | 35.0 Percentage of participants |
Secondary
Duration of Response (DOR) Assessed by the Investigator
DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first assessed by the investigator based on the IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment and had a CR or PR response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 | Duration of Response (DOR) Assessed by the Investigator | 25.0 Months |
| Cohort 2 | Duration of Response (DOR) Assessed by the Investigator | 16.4 Months |
| Cohort 3 | Duration of Response (DOR) Assessed by the Investigator | 24.7 Months |
Secondary
Duration of Response (DOR) Based on BICR
DOR for the subgroup of participants who achieved a CR or PR by independent central review, is the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of PD or to death due to any cause, whichever comes first based on BICR. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The analysis used the Kaplan-Meier method, with participants with response censored at their last assessment, and there was no progressive disease at the time of the last disease assessment.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment and had a CR or PR response.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 | Duration of Response (DOR) Based on BICR | 25.0 Months |
| Cohort 2 | Duration of Response (DOR) Based on BICR | 11.1 Months |
| Cohort 3 | Duration of Response (DOR) Based on BICR | 24.4 Months |
Secondary
Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria
ORR is the percentage of participants who had a CR or PR prior to disease progression assessed by the investigator using IWG criteria. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria | 72.5 Percentage of participants |
| Cohort 2 | Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria | 66.7 Percentage of participants |
| Cohort 3 | Overall Response Rate (ORR) Assessed by Investigator Based on IWG Criteria | 71.7 Percentage of participants |
Secondary
Overall Response Rate (ORR) by BICR Based on Lugano Criteria
ORR is the percentage of participants who had a CR or PR prior to disease progression based on the Lugano criteria using BICR. CR is the disappearance of all evidence of disease and PR is the regression of measurable disease and no new sites. The point estimate and 95% 2-sided exact confidence interval (CI) used the Clopper-Pearson method. An exact binomial test was conducted for each cohort versus a fixed control rate for each cohort.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Cohort 1 | Overall Response Rate (ORR) by BICR Based on Lugano Criteria | 82.6 Percentage of participants |
| Cohort 2 | Overall Response Rate (ORR) by BICR Based on Lugano Criteria | 67.9 Percentage of participants |
| Cohort 3 | Overall Response Rate (ORR) by BICR Based on Lugano Criteria | 68.3 Percentage of participants |
Secondary
Overall Survival (OS)
OS is the time from the first dose to death due to any cause. The Kaplan-Meier method was used to estimate the survival curve, separately by Cohort with missing data censored at last assessment.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 | Overall Survival (OS) | NA Months |
| Cohort 2 | Overall Survival (OS) | NA Months |
| Cohort 3 | Overall Survival (OS) | NA Months |
Secondary
Progression-free Survival (PFS) Assessed by the Investigator
PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first assessed by the investigator based on the IWG criteria. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 | Progression-free Survival (PFS) Assessed by the Investigator | 24.9 Months |
| Cohort 2 | Progression-free Survival (PFS) Assessed by the Investigator | 13.9 Months |
| Cohort 3 | Progression-free Survival (PFS) Assessed by the Investigator | 22.0 Months |
Secondary
Progression-free Survival (PFS) Based on BICR
PFS is the time from first dose to the first documented progressive disease (PD) or death due to any cause, whichever occurs first based on BICR. For those who have PD, the true date of disease progression was approximated by the date of the first assessment at which PD is objectively documented per IWG criteria, regardless of discontinuation of study drug. Death is always considered as a confirmed PD event. The non-parametric Kaplan-Meier method was used to estimate the PFS curve with missing data censored at last assessment.
Time frame: Up to approximately 99 months
Population: All allocated participants who received at least 1 dose of study treatment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 | Progression-free Survival (PFS) Based on BICR | 16.5 Months |
| Cohort 2 | Progression-free Survival (PFS) Based on BICR | 11.1 Months |
| Cohort 3 | Progression-free Survival (PFS) Based on BICR | 19.7 Months |