E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), cervical cancer, and triple-negative breast cancer (TNBC) |
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E.1.1.1 | Medical condition in easily understood language |
Non-small cell lung cancer (NSCLC), biliary tract cancer (BTC), cervical cancer, and triple-negative breast cancer (TNBC) |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10061873 |
E.1.2 | Term | Non-small cell lung cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10073077 |
E.1.2 | Term | Intrahepatic cholangiocarcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10074879 |
E.1.2 | Term | Extrahepatic cholangiocarcinoma |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10017614 |
E.1.2 | Term | Gallbladder cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008229 |
E.1.2 | Term | Cervical cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 20.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10075566 |
E.1.2 | Term | Triple negative breast cancer |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate clinical safety of bintrafusp alfa in participants with solid tumors who continue treatment after completion of the primary/main analyses in parent bintrafusp alfa studies |
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E.2.2 | Secondary objectives of the trial |
To evaluate clinical efficacy of bintrafusp alfa based on overall survival |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Are ≥ 18 years of age at the time of signing the informed consent. In Japan, if a participant is at least 18 but < 20 years of age, written informed consent from his/her parent or guardian will be required in addition to the participant’s written consent.
2. Are participants currently enrolled in an eligible bintrafusp alfa parent study, as indicated in the protocol, where the primary/main analysis has been completed or after discontinuation of study before primary/main analysis has been completed and who:
• Are currently on active bintrafusp alfa treatment (alone as a monotherapy or following discontinuation of other combination treatment agents) in the parent study and without treatment interruption at the time of rollover study enrollment, OR.
• Experienced a confirmed CR, PR, or SD in an eligible parent study, discontinued bintrafusp alfa treatment according to the parent study protocol, and subsequently developed disease progression and are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants’ physicians OR.
• Discontinued from bintrafusp alfa treatment in an eligible parent study due to an AE(s) that was subsequently well controlled or completely resolved after stopping therapy, provided that the parent study protocol permits reinitiation of bintrafusp alfa if a participant discontinued treatment due to toxicity and these participants are willing to re-start bintrafusp alfa treatment deemed potentially beneficial by the participants’ physicians. Participants who have had AEs requiring permanent treatment discontinuation, like certain irAEs or certain bleeding events, as described in the protocol, are excluded from participation in this Rollover study.
• Have completed End of treatment (EoT) assessment of a parent study.
3. Male and Female participants must agree to use appropriate contraception and barriers, if applicable. For female participants of childbearing potential or for male participants who have female partners of childbearing potential, the following applies:
Participants on active treatment must agree to continue to use highly effective contraception (i.e., methods with a failure rate of less than 1% per year; as described in the protocol) for both male and female participants if the risk of conception exists (Note: The effects of the study intervention on the developing human fetus are unknown as described in the protocol; thus, women of childbearing potential and men must agree to use highly effective contraception as stipulated in national or local guidelines). Highly effective contraception must be used 28 days prior to the first study intervention administration, for the duration of study intervention, and at least for 2 months (for female participants) or 4 months (for male participants) after stopping study intervention. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, the treating physician should be informed immediately.
4. Capable of giving signed informed consent as indicated in the protocol and to comply with the requirements and restrictions listed in the ICF and this protocol. |
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E.4 | Principal exclusion criteria |
1. Pregnancy or currently in lactation.
2. Known hypersensitivity to any of the study intervention ingredients.
3. For participants reinitiating treatment with bintrafusp alfa at study entry: have received any systemic anticancer therapies/treatments since discontinuing bintrafusp alfa treatment.
4. Concurrent treatment with prohibited drugs as indicated in the protocol.
5. Participant has withdrawn consent from the parent study for any reason.
6. Any other reason that, in the opinion of the Investigator, precludes the participant from participating in the study. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Occurrence of AEs and treatment-related AEs |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Starting from baseline in parent study |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Starting from baseline in parent study |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 8 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Australia |
Brazil |
China |
Japan |
Korea, Republic of |
Turkey |
Ukraine |
United States |
Belgium |
France |
Italy |
Spain |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the study is defined as the date of the last scheduled procedure shown in the SoA for the last participant in the study and when there are no other eligible parent studies ongoing from which participants could enroll in this rollover study. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 3 |
E.8.9.2 | In all countries concerned by the trial days | 0 |